Closure system and methods of use

ABSTRACT

A closure system and methods of use are provided for use in sealing an opening in a body tissue, such as a vascular puncture site. A method of closing the opening in the body tissue can be performed with the closure system having a closure clip. The method can include positioning the closure clip in a first closure clip position adjacent to the opening in the body tissue such that a plurality of spikes of the closure clip are inserted into the tissue at a location outward from a central axis of the opening. Subsequently, the closure clip can be positioned in a second closure clip position such that the plurality of spikes are pulled inward toward the central axis of the opening so as to pull the tissue between the opening and each of the spikes together and close the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This U.S. Patent Application is a continuation-in-part of U.S.application Ser. No. 10/264,306, filed Oct. 3, 2002, now U.S. Pat. No.7,901,428, which is a continuation of U.S. patent application Ser. No.09/546,998, filed Apr. 11, 2000, now U.S. Pat. No. 6,461,364, which is acontinuation-in-part of U.S. patent application Ser. No. 09/478,179,filed Jan. 5, 2000, now U.S. Pat. No. 6,197,042. Additionally, this U.S.Patent Application is a continuation-in-part of U.S. application Ser.No. 11/198,811, filed Aug. 4, 2005, now U.S. Pat. No. 7,828,817, whichis a continuation of U.S. patent application Ser. No. 10/081,723, filedFeb. 21, 2002, now U.S. Pat. No. 6,942,674, which is acontinuation-in-part of U.S. patent application Ser. No. 09/732,835,filed Dec. 7, 2000, now U.S. Pat. No. 6,780,197, which is acontinuation-in-part of U.S. patent application Ser. No. 09/610,238,filed Jul. 5, 2000, now U.S. Pat. No. 6,391,048, which is acontinuation-in-part of U.S. patent application Ser. No. 09/478,179,filed Jan. 5, 2000, now U.S. Pat. No. 6,197,042. Also, this U.S. PatentApplication is a continuation-in-part of U.S. application Ser. No.10/006,400, filed Nov. 30, 2001, now U.S. Pat. No. 7,842,068, which is acontinuation-in-part of U.S. patent application Ser. No. 09/732,835,filed Dec. 7, 2000, now U.S. Pat. No. 6,780,197, which is acontinuation-in-part of U.S. patent application Ser. No. 09/610,238,filed Jul. 5, 2000, now U.S. Pat. No. 6,391,048, which is acontinuation-in-part of U.S. patent application Ser. No. 09/478,179,filed Jan. 5, 2000, now U.S. Pat. No. 6,197,042. This U.S. PatentApplication is also a continuation-in-part of U.S. patent applicationSer. No. 10/147,774, filed May 17, 2002, now U.S. Pat. No. 7,931,669,which is a continuation-in-part of U.S. patent application Ser. No.09/610,238, filed Jul. 5, 2000, now U.S. Pat. No. 6,391,048, which is acontinuation-in-part of U.S. patent application Ser. No. 09/478,179,filed Jan. 5, 2000, now U.S. Pat. No. 6,197,042. All foregoing patentsand applications are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates to apparatus and methods for sealing aniatrogenic puncture in a vessel or other body lumen formed inconjunction with a diagnostic or therapeutic treatment. Moreparticularly, the present invention provides apparatus comprising anintroducer sheath including a puncture site closure device comprising anexpandable clip with elastic memory. Also, the present inventionprovides apparatus comprising an introducer sheath including a puncturesite closure device comprising a bioabsorbable clip. Further, thepresent invention includes an apparatus and methods for positioning sucha device relative to the body lumen before delivery

2. The Relevant Technology

Catheterization and interventional procedures, such as angioplasty andstenting, generally are performed by inserting a hollow needle through apatient's skin and muscle tissue into the vascular system. A guide wirethen is passed through the needle lumen into the patient's blood vessel.The needle is removed and an introducer sheath is advanced over theguide wire into the vessel. A catheter typically is passed through thelumen of the introducer sheath and advanced over the guide wire intoposition for a medical procedure. The introducer sheath thereforefacilitates insertion of various devices into the vessel whileminimizing trauma to the vessel wall and minimizing blood loss during aprocedure.

Upon completion of the medical procedure, the catheter and introducersheath are removed, leaving a puncture site in the vessel. Commonly,external pressure is applied until clotting and wound sealing occurs.However, this procedure is time consuming and expensive, requiring asmuch as an hour of a physician's or nurser's time, is uncomfortable forthe patient, and requires that the patient be immobilized in theoperating room, cathlab, or holding area. Furthermore, a risk ofhematoma exists from bleeding prior to hemostasis.

Various apparatus have been developed for percutaneously sealing avascular puncture by occluding or suturing the puncture site. Forexample, U.S. Pat. Nos. 5,192,302 and 5,222,974 to Kensey et al.,describe the use of a biodegradable plug delivered through theintroducer sheath into the puncture site. When deployed, the plug sealsthe vessel and provides hemostasis. Such devices have been slow to gainacceptance in the medical community, however, due to difficultiesencountered in positioning the plug within the vessel. Moreover, theagents used to occlude the puncture site are animal-derived, typicallycollagen-based. Thus, a risk of adverse immunoresponse exists.

Another previously known technique comprises percutaneously suturing thepuncture site with specialized apparatus. Such apparatus is described,for example, in U.S. Pat. No. 5,304,184 to Hathaway et al. Whilepercutaneous suturing devices may be effective, a significant degree ofskill may be required on the part of the practitioner. Because suchdevices are mechanically complex, they tend to be relatively expensiveto manufacture.

Surgical staples and resilient clips for external skin wound closure arewell known in the art, Examples include U.S. Pat. No. 5,026,390 to Brownand U.S. Pat. No. 5,683,405 to Yacoubian et al, which both describeresiliently deformable closure devices suitable for manual externalapplication.

To reduce the cost and complexity of percutaneous puncture closuredevices, such devices employing resilient clips or staples have beendeveloped. U.S. Pat. No. 5,478,354 to Tovey et al. describes the use ofresilient clips in conjunction with a trocar to close abdominal puncturewounds. U.S. Pat. No. 5,810,846 to Vimich et al. describes a specializedapparatus for closing a vascular puncture site with a plasticallydeformable clip. The apparatus preferably is advanced over a guide wirethrough a cannula to the surface of the puncture site, where thestaple-like clips are delivered to close the wound.

U.S. Pat. No. 5,782,861 to Cragg et al. describes specialized apparatusfor closing a puncture site with a detachable clip. The apparatuscomprises a hollow shaft, having a distal end formed with one or moreopposed pairs of resilient grasping prongs, that is advanced over aguide wire through a coaxial hollow tube to a position at the distal endof the tube just proximal of the puncture. The grasping prongs areextended beyond the distal end of the tube to grasp the vessel onopposing sides of the puncture. The shaft then is partially retracted,causing the prongs to contract within the tube, thereby sealing thepuncture site. Both of the devices described in the foregoing patentshave the drawback that a separate device must be deployed through theintroducer sheath to close the puncture site, thus prolonging theprocedure. Moreover, both devices require relatively complex apparatusand involve time consuming manipulation to achieve hemostasis.

The use of back bleed indication as a positioning technique within avascular puncture is known. For example, U.S. Pat. No. 4,317,445 toRobinson describes a flashback chamber for providing visual indicationof venous entry of a cannula. However, that device does not discussvascular wound closure. U.S. Pat. No. 5,676,689 to Kensey et al., whichclaims priority from the U.S. Pat. No. 5,222,974 discussed above, uses avessel location device to simplify positioning of the biodegradableplug. The vessel locator enables blood from the vessel to flow therethrough so that the position of the vessel may be determined. However,the Kensey system only proffers one closure device, and that device iscomplex and raises concerns about biocompatibility. It also requires theclosure component to be positioned within the puncture, therebyincreasing the likelihood of dangerous over-advancement of the plug intothe vessel.

The percutaneous puncture closure devices described in the foregoingpatents generally have the drawback that they require relatively complexmechanisms and require time consuming manipulation to achievehemostasis. It therefore would be desirable to provide apparatus andmethods suitable for vascular puncture closure that overcome thesedisadvantages of previously known devices. It also would be desirable toprovide apparatus and methods for vascular puncture closure that quicklyand effectively achieve hemostasis. It further would be desirable toprovide vascular puncture closure apparatus and methods that do notrequire the introduction of additional apparatus at the completion ofthe catheterization procedure to achieve closure. It still further wouldbe desirable to provide apparatus and methods suitable for vascularpuncture closure that do not introduce animal-derived material into thebloodstream. It still further would be desirable to provide apparatusand methods wherein all foreign materials left in a patient's body arebioabsorbable.

BRIEF SUMMARY OF THE INVENTION

Generally, embodiments of the present invention can include medicaldevices and methods of using the same for closing an opening in a bodytissue. Such methods can include the following: positioning a closureclip in a first closure clip position adjacent to the opening in thebody tissue such that a plurality of spikes of the closure clip areinserted into the tissue at a location outward from a central axis ofthe opening; and positioning the closure clip in a second closure clipposition such that the plurality of spikes are pulled inward toward thecentral axis of the opening so as to pull the tissue between the openingand each of the spikes together and close the opening. Additionally, theclosure clip can be released from a distal end of a closure clipapplicator when adjacent to the opening in the tissue. This can befacilitated when the closure clip applicator is positioned adjacent tothe opening in the body tissue by using a sheath such that the sheathguides the positioning of the applicator.

Moreover, the sheath can be positioned relative to the opening in thetissue with a guide before the closure clip applicator is positionedadjacent to the opening. During positioning of the sheath, the guide canhave a distal portion that extends through the opening of the bodytissue and a proximal portion that can be disposed within a lumen of thesheath. This can allow for the guide to center the sheath at the centralaxis of the opening, which in turn can facilitate the sheath centeringthe spikes of the closure clip around the opening of the tissue withrespect to the central axis when the closure clip is in the secondposition.

Another embodiment of a method of closing an opening in a body tissuecan include the following: positioning a closure clip applicatoradjacent to the opening in the body tissue, the closure clip applicatorhaving a closure clip in a radially expanded position at a distal end ofthe closure clip applicator; positioning the radially expanded closureclip into a first closure clip position adjacent to the opening in thebody tissue such that a plurality of spikes of the closure clip areinserted into the tissue at a location outward from a central axis ofthe opening; and contracting the radially expanded closure clip to asecond closure clip position such that the plurality of spikes arepulled inward toward to central axis of the opening so as to pull thetissue between the opening and each of the spikes together and close theopening. Additionally, the closure clip can be released from a distalend of the closure clip applicator when adjacent to the opening in thetissue. This can be facilitated when the closure clip applicator ispositioned adjacent to the opening in the body tissue by using a sheathsuch that the sheath guides the positioning of the applicator.

Moreover, the sheath can be positioned relative to the opening in thetissue with a guide before the closure clip applicator is positionedadjacent to the opening. During positioning of the sheath, the guide canhave a distal portion that extends through the opening of the bodytissue and a proximal portion that can be disposed within a lumen of thesheath. This can allow for the guide to center the sheath at the centralaxis of the opening, which in turn facilitates the sheath centering thespikes of the closure clip around the opening of the tissue with respectto the central axis when the closure clip is in the second position.

Yet another embodiment of a method of closing an opening in a bodytissue can include the following: inserting a guide through the openingin the body tissue; using the guide to position a closure clipapplicator adjacent to the opening in the body tissue with the guide,the closure clip applicator having a closure clip in a radially expandedposition at a distal end of the closure clip applicator; positioning theradially expanded closure clip into a first closure clip positionadjacent to the opening in the body tissue such that a plurality ofspikes of the closure clip are inserted into the tissue at a locationoutward from a central axis of the guide; and contracting the radiallyexpanded closure clip to a second closure clip position such that theplurality of spikes are pulled inward toward to central axis of theguide so as to pull the tissue between the opening and each of thespikes together and close the opening. Additionally, the closure clipcan be released from the distal end of a closure clip applicator whenadjacent to the opening in the tissue. This can be facilitated when theclosure clip applicator is positioned adjacent to the opening in thebody tissue by using a sheath such that the sheath guides thepositioning of the applicator.

Moreover, the sheath can be positioned relative to the opening in thetissue with the guide before the closure clip applicator is positionedadjacent to the opening. During positioning of the sheath, the guide canhave a distal portion that extends through the opening of the bodytissue and a proximal portion that can be disposed within a lumen of thesheath. This can allow for the guide to center the sheath at the centralaxis of the opening, which in turn can facilitate the sheath centeringthe spikes of the closure clip around the opening of the tissue withrespect to the central axis when the closure clip is in the secondposition.

These and other embodiments and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings.

FIG. 1 is a side view of a vascular device constructed in accordancewith the present invention.

FIG. 2 is a cross sectional view of the closure component of thevascular device of FIG. 1.

FIGS. 3A-3D are side views of the resilient clip of the presentinvention shown from different angles in an expanded deliveryconfiguration and in an unstressed deployed configuration.

FIGS. 4A and 4B are isometric views of an alternative embodiment of theresilient surgical clip, constructed in accordance with the presentinvention and shown, respectively, in an unstressed deployedconfiguration and in an expanded delivery configuration.

FIGS. 5A-5F are side-sectional views of a vascular puncture site,illustrating a method of sealing the puncture site with the integratedvascular device of FIG. 1.

FIG. 6 is a side view of an integrated vascular device constructed inaccordance with the present invention.

FIGS. 7A-7C are, respectively, a cross-sectional view of a closurecomponent of the vascular device of FIG. 6, an exploded side view ofproximal slots of the closure component, and an exploded side view ofdistal slots.

FIGS. 8A-8C are, respectively, views of a bioabsorbable clip andfastener of the present invention shown in top view in a deliveryconfiguration, in side view in the delivery configuration, and in sideview in a deployed configuration.

FIGS. 9A and 9B are isometric views of an alternative embodiment of thebioabsorbable surgical clip and fastener, constructed in accordance withthe present invention and shown, respectively, in a deliveryconfiguration and in a deployed configuration.

FIGS. 10A-10B through 13A-13B are side-sectional views of the closurecomponent of FIG. 7A in use at a vascular puncture site, withcorresponding side views of the proximal and distal slots of FIGS. 7Band 7C, illustrating a method of sealing the puncture site with thepresent invention.

FIG. 14 is a side view of a preferred embodiment of an integratedvascular device constructed in accordance with the present invention.

FIG. 15 is a side-sectional view of a sealing device for use with thevascular device of FIG. 14.

FIGS. 16A-16B through 19A-19B are side views of the closure component ofFIG. 14 in use at a vascular puncture site, shown in section, with thesealing device of FIG. 15, illustrating a method of sealing the puncturesite, and corresponding top views of the vascular puncture site.

FIGS. 20A-20C are side-sectional views of an alternative embodiment ofan integrated vascular device of the present invention in use at avascular puncture site, illustrating a method of sealing the puncturesite.

FIGS. 21A-21E are side-sectional views of a further alternativeembodiment in use at a vascular puncture site, illustrating a method ofsealing the puncture site.

FIGS. 22A and 22B are isometric views of a section of vessel includingand corresponding to the vascular puncture site of FIGS. 21A-21E,further illustrating the methods of FIGS. 21A-21E.

FIG. 23 is a side view of an apparatus for delivering a closure element,including an introducer sheath, a locator, and an actuator assembly, inaccordance with the present invention.

FIG. 24 is a side view of the apparatus of FIG. 23, with the locatordisposed within the sheath, and a housing on the sheath advanced to adelivery position.

FIGS. 25A and 25B are perspective views of the distal end of theapparatus of FIGS. 23 and 24, showing positioning elements on thelocator in collapsed and expanded configurations, respectively.

FIGS. 26A-26F are cross-sectional views of a blood vessel, showing amethod for delivering a closure device into a passage communicating withthe vessel.

FIG. 27 is a cross-sectional view of the blood vessel of FIG. 26D,showing the positioning elements engaging a wall of the vessel.

FIG. 28 is a perspective view of an alternate embodiment of a distalportion of the locator with the positioning elements disposed in theirexpanded configuration.

FIGS. 29A and 29B are side views of another embodiment of a distalportion of a locator with positioning elements disposed in collapsed andexpanded configurations, respectively.

FIGS. 30A and 30B are side views of the locator of FIGS. 29A and 29B,including a control on the locator for adjusting the expansion of thepositioning elements.

FIG. 31 is a cross-section view of a distal portion of an alternativeembodiment of an apparatus for delivering a closure element, inaccordance with the present invention.

FIG. 32 is a cross-sectional view of a distal portion of yet anotheralternative embodiment of an apparatus for delivering a closure element,in accordance with the present invention.

FIG. 33 is an exploded side view of a first preferred embodiment of anapparatus for delivering a closure element, including an introducersheath, and an actuator assembly, in accordance with the presentinvention.

FIG. 34 is a perspective view of the actuator assembly for the apparatusof FIG. 33.

FIG. 35A is an exploded perspective view of the apparatus of FIG. 33.

FIG. 35B is a side of view of an obturator assembly for the actuatorassembly of FIGS. 33-34A.

FIG. 36 is a partially exploded perspective view of the introducersheath shown in FIGS. 33 and 35A.

FIG. 37 is an exploded perspective view of a hub assembly of theintroducer sheath shown in FIG. 36.

FIG. 38A is an exploded perspective view of a carrier assembly,including a carrier member, a pusher member, and an anchor member, foruse with the apparatus of FIGS. 33-37.

FIG. 38B is a perspective view of the carrier assembly of FIG. 38A, withthe carrier, pusher, and anchor members assembled substantiallycoaxially with respect to one another.

FIG. 38C is a side view of the carrier assembly of FIGS. 38A and 38B,showing slots in an outer sleeve expanding to accommodate advancing thecarrier and pusher members relative to the anchor member.

FIG. 38D is a side view of an alternative embodiment of the carrierassembly of FIG. 38C, showing spiral slots in the outer sleeve.

FIGS. 39A and 39B are perspective views of the carrier assembly of FIGS.38A and 38B aligned with and attached to a distal end of the actuatorassembly of FIG. 33, respectively.

FIGS. 40A and 40B are cross-sectional details of telescoping tubularmembers of the actuator assembly of FIGS. 33-35B, showing cooperatingdetents for releasably coupling an outer tubular member to inner andintermediate tubular members.

FIGS. 41A-41D are cross-sectional details of the telescoping tubularmembers of FIGS. 40A and 40B, showing cooperating detents for releasablycoupling the inner and intermediate tubular members.

FIGS. 42A and 42B are perspective views of the distal end of theobturator of FIG. 35B, showing positioning elements on the obturator incollapsed and expanded configurations, respectively.

FIGS. 43A and 43B are side views of a second preferred embodiment of anapparatus for delivering a closure element, in accordance with thepresent invention.

FIGS. 44A-44H are cross-sectional views of a blood vessel, showing amethod for delivering a clip into an interstitial region of a passagecommunicating with the vessel.

FIG. 44I is a cross-sectional view of the vessel of FIGS. 44A-44H,showing an alternative method wherein the clip is delivered into thewall of the vessel.

FIGS. 45A and 45B are side views of another preferred embodiment of alocator device, in accordance with the present invention.

FIG. 46A is an exploded perspective view of an apparatus for delivering,a closure device, including the locator device of FIGS. 45A and 45B.

FIG. 46B is a perspective view of the apparatus of FIG. 46A afterassembly, and with the locator device deployed.

FIGS. 47A-47D are cross-sectional side views, showing a method fordelivering a plug member using the apparatus of FIGS. 46A and 46B.

FIG. 48 is a detail of FIG. 47C, showing activation of the locatormember with a blood vessel.

FIGS. 49A-49D are cross-sectional side views, showing another method fordelivering a plug member using the apparatus of FIGS. 44A and 44B.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Generally, the present invention can provide vascular puncture closureapparatus and methods that overcome disadvantages of previously knowndevices. Also, the invention can provide apparatus and methods suitablefor vascular puncture closure that quickly and effectively achievehemostasis. Additionally, the invention can provide apparatus andmethods for vascular puncture closure that do not require theintroduction of additional apparatus at the completion of thecatheterization procedure to achieve closure. Further, the invention canprovide vascular puncture closure apparatus and methods that do notintroduce animal-derived material into the bloodstream. Furthermore, theinvention can provide apparatus and methods wherein all foreignmaterials left in a patient's body are bioabsorbable. Moreover, theinvention can provide vascular puncture closure apparatus and methodsthat are safe, lower cost, and easy to use.

I. Closure Systems

Generally, the present invention can include a medical instrument forwound closure. As such, the invention can include a vascular introducersheath having an integrated wound closure component. The closurecomponent consists of a resilient spring clip disposed on andadvanceable over the exterior of the introducer sheath in an expandeddelivery configuration until opposite sides of the clip pierce a vesselon opposite sides of a puncture site. The introducer sheath is thenwithdrawn, enabling the spring clip to contract to its unstresseddeployed configuration, thereby drawing opposite sides of the puncturetogether and closing the wound. Means also are provided for confirmingwhen the spring clip has engaged the vessel wall, thereby indicating tothe surgeon that the clip may be deployed and the introducer sheath maybe withdrawn. Alternative embodiments of the spring clip also areprovided.

Additionally, the closure component can consist of a bioabsorbable anddeformable clip with a bioabsorbable fastener and is disposed on andadvanceable over the exterior of the introducer sheath in an expandeddelivery configuration until opposite sides of the clip pierce a vesselon opposite sides of a puncture site. The clip is then mechanicallydeformed with the fastener into a deployed configuration, therebydrawing opposite sides of the puncture together and closing the wound.Means also are provided for confirming when the bioabsorbable clip hasengaged the vessel wall to indicate to the surgeon that the clip may bedeployed and the introducer sheath may be withdrawn.

In a preferred embodiment, the bioabsorbable clip resembles an inverted“Y” with pointed ends that puncture the vessel to be closed. Thefastener comprises a bioabsorbable locking collar that may be advanceddown the length of the clip to bring the pointed ends together.

In another embodiment, the bioabsorbable clip comprises a hoop withpointed legs extending therefrom. The hoop has two points of reducedthickness spaced 180 degrees apart on the circumference of the hoop. Thefastener comprises a bioabsorbable conical wedge that is pushed downinto the hoop to force opposing sides of the hoop towards one anotherand bring the pointed legs together.

In another embodiment, the present invention includes an integratedvascular device comprising a sheath having a puncture closure componentand puncture sealant. The closure component is disposed on andadvanceable over the exterior of the sheath, which may, for example,comprise an introducer sheath, a trocar, or a catheter. The closurecomponent may comprise any of a variety of apparatus suited to close avascular puncture. Once the closure component has been actuated to closethe puncture, sealant is introduced to the exterior surface of theclosed puncture, preferably through the sheath's interior lumen, wherethe sealant seals the puncture closed. The sheath with closure componentis then removed from the patient.

In a preferred embodiment constructed in accordance with the presentinvention, the closure component comprises a twist closure device. Thedevice pierces tissue surrounding the vascular puncture and then isrotated to close the wound. In an alternative embodiment, the closurecomponent comprises needles and an elastic segment surrounding theneedles. The needles pierce the puncture with the elastic segmentexpanded. The segment is then allowed to resiliently contract to anunstressed configuration of smaller diameter, thereby drawing theneedles together and closing the wound.

In a still further alternative embodiment, the needles, or prongs, areelastically deformed to an expanded diameter, in which they pierce thetissue adjacent to puncture. The needles then are allowed to resilientlycontract to an unstressed configuration of smaller diameter, therebyclosing the wound.

Sealant then may be introduced, preferably through the interior lumen ofthe sheath, to seal the puncture closed. The sealant may comprise any ofa variety of sealants, per se known, including adhesives, sutures, andclips, all of which are preferably bioabsorbable. Alternatively, theclosure component may further comprise the sealant, wherein the closurecomponent is left in place within the vessel until hemostasis naturallyoccurs, or wherein the closure component comprises a monopolar electrodeor opposed bipolar electrodes that cauterize the wound with RF current.In addition to cauterization, RF energy generates heat that beneficiallycauses shrinkage of the vascular tissue, thereby assisting closure ofthe wound. Thermal energy from electrical induction, infrared light,ultrasonic vibration, microwave or laser irradiation, and other meansmay also be used to seal the puncture.

In one embodiment, an apparatus is provided for delivering a closureelement into engagement with tissue adjacent an opening into a bodylumen. The apparatus includes a sheath including a lumen extendingbetween its proximal and distal ends, and a locator member disposedwithin the sheath, the locator member having a distal portion extendingdistally beyond the distal end of the sheath. One or more positioningelements are provided on the distal portion of the locator member, thepositioning elements being selectively expandable between asubstantially axial collapsed configuration and a substantiallytransverse expanded configuration. Preferably, the positioning elementsare a plurality, e.g. two or more, equally spaced, substantiallyflexible splines or wings configured for expanding substantiallytransversely to a longitudinal axis of the sheath. Each spline may havea first fixed end and a second movable end, the second end being axiallymovable towards the first end to cause an intermediate region of thespline to expand radially outward, thereby defining the radiallyexpanded configuration. Alternatively, the splines may include aplurality of substantially rigid or semi-rigid elements that are hingedsuch that the splines may be expanded to the expanded configuration.

An actuator may be coupled to the locator member, the actuatorconfigured for controllably expanding the positioning elements from thecollapsed configuration to the expanded configuration. The actuator mayinclude a control such that the positioning elements may be selectivelyexpanded to one of a plurality of expanded sizes, e.g., to accommodateinsertion into vessels of various sizes.

A housing may be axially slidably disposed on an exterior of the sheath,the housing configured for releasably holding a closure element, thehousing being actuable for advancing the closure element distally todeploy the closure element. In a preferred embodiment, the locatoractuator may be configured for automatically collapsing the positioningelements to the collapsed configuration upon advancement of the housingto prevent engagement between the closure element and the positioningelements. The housing may be substantially permanently but slidablydisposed on the sheath. Alternatively, the housing may be providedseparate from the sheath, e.g., with the closure element pre-loadedtherein. The housing may be directed over the sheath, e.g., over theproximal end of the sheath, at any time before delivery of the closureelement.

In another embodiment, a method is provided for delivering a closureelement into a passage communicating with an opening in a wall of a bodylumen. An introducer sheath is positioned through a patient's skintowards the body lumen via the passage, the sheath including a lumenextending between its proximal and distal ends. One or more instrumentsmay be introduced through the lumen of the sheath into the body lumen. Adiagnostic or therapeutic procedure may be performed using the one ormore instruments at a location accessed via the body lumen.

In a preferred embodiment, the body lumen is a blood vessel, such as aperipheral vessel, e.g., the femoral or carotid artery. The proceduremay be any of a variety of endovascular procedures, such as angioplasty,atherectomy, stent delivery, delivery of a therapeutic agent, and tissueablation. Upon completion of the procedure, the devices may be removedfrom the sheath. A locator may be inserted along or through the sheathuntil a distal portion of the locator extends beyond the distal end ofthe sheath and into the body lumen. One or more positioning elements onthe distal portion of the locator may be expanded from a collapsedconfiguration to an expanded configuration. The sheath and locator maythen be manipulated with respect to the body lumen until the positioningelements in their expanded configuration contact the wall of the bodylumen, thereby providing a tactile indication of a location of thedistal end of the sheath. A closure element may then be delivered viathe sheath into the passage. The sheath and locator may be withdrawnfrom the body lumen and opening, leaving the closure element tosubstantially close the opening.

In one embodiment, an apparatus is provided for delivering a closureelement or other annular-shaped device into an opening through tissue,e.g., for engaging tissue adjacent to the opening to close and/or sealthe opening. The apparatus includes an elongate member includingproximal and distal ends, such as an introducer sheath that includes alumen for advancing one or more devices into a body lumen during aprocedure.

A carrier assembly is slidable on the elongate member, the carrierassembly including an inner carrier member, a middle pusher member, and,optionally, an outer skin, nested together. Each member may have anannular shape, and may include a connector on its proximal end. Thepusher member may be disposed about the carrier member to define a spacedistal to the pusher member along an outer surface of the carriermember. The outer skin has a length, whereby the outer skin may extendover the space and/or contact an outer surface of the elongate member.In a preferred embodiment, the outer skin extends a short distancebeyond a distal end of the carrier member, such that the outer skin isslidable along the elongate member. An annular-shaped element, e.g., aclip or other closure device, may be received on the carrier memberwithin the space, the annular-shaped element being deployable from thespace upon distal movement of the pusher member relative to the carriermember.

In addition, the apparatus may include an actuator assembly including ahousing and inner, intermediate, and outer actuator members thattelescope relative to the housing and/or to each other. The housing maybe connectable to the proximal end of the elongate member, e.g., to ahub on the proximal end by cooperating connectors on the hub and thehousing. Each actuator member may include a connector on its distal endfor engaging a respective member of the carrier assembly, therebycoupling movement of the carrier, pusher, and sheath members to theinner, intermediate, and outer actuator members, respectively. If theouter skin is eliminated from the carrier assembly, the outer actuatormember may be eliminated from the actuator assembly.

In a preferred embodiment, the actuator assembly includes a controlmember that is coupled to one or more of the actuator members,preferably, but not necessarily, the intermediate actuator member. Theinner, intermediate, and outer actuator members may include cooperatingdetents for coupling distal movement of the inner, intermediate, andouter actuator members together in a predetermined manner as the controlmember is directed distally.

For example, a first set of cooperating detents may be provided thatinitially couples the inner, intermediate, and outer actuator memberstogether, and releases the outer actuator member upon attaining a firstdistal position. The inner and intermediate actuator members may bedirected distally further, consequently permitting the carrier and/orpusher members to be directed distally relative to the outer skin. In anexemplary embodiment, the first set of cooperating detents may include afirst detent on the outer tubular member and first pockets in the innerand intermediate tubular members for receiving the first detent therein.Cooperating ramps may be provided on the outer tubular member that areconfigured for disengaging the first detent from the first pockets uponattaining the first distal position, thereby allowing the inner andintermediate tubular members to be directed distally beyond the firstdistal position.

In addition, the cooperating detents may include a second set ofcooperating detents on the inner and intermediate actuator members forcoupling movement of the inner and intermediate actuator memberstogether to a second distal position distal to the first distalposition. For example, the intermediate actuator member may include asecond detent, and the inner actuator member may include a second pocketfor receiving the second detent therein. The housing or the outeractuator member may include a spring element for disengaging the seconddetent from the second pocket upon attaining the second distal position.For example, the spring element may include a beam extending from theouter tubular member through slots in the inner and intermediate tubularmembers, the beam being received in the second pocket upon attaining thesecond distal position, thereby disengaging the second detent andallowing further distal movement of the intermediate member whilesubstantially simultaneously coupling the inner and outer tubularmembers together.

The intermediate actuator member may be advanced distally beyond thesecond distal position by directing the control member further distally,thereby directing the pusher member distally with respect to the carriermember to deploy the annular-shaped element from the space.

In addition, the actuator assembly may also include an obturator orlocator member that may be part of the actuator assembly or may beconnected to the actuator assembly. A distal portion of the locatormember may extend distally beyond the actuator members. In addition, thelocator member has sufficient length such that the distal portion mayextend beyond the distal end of the elongate member when the actuatorassembly is connected to the elongate member. One or more positioningelements on the distal portion of the locator member may be movable froma collapsed configuration towards a transversely expanded configuration.A locking mechanism on the locator member and/or actuator assembly mayreleasably retain the positioning elements in the expandedconfiguration.

In a preferred embodiment, the locator member is substantiallypermanently attached to the actuator assembly such that the distalportion extends through and beyond the inner actuator member.Alternatively, the actuator assembly may include a tubular portion orrecess communicating via an interior of the inner actuator member with alumen of the elongate member. In this embodiment, the locator member maybe inserted into the tubular portion until the positioning elements aredisposed beyond the distal end of the elongate member. One of the inner,intermediate, and outer actuator members may include a third detent forengaging a release mechanism for disengaging the locking mechanism onthe locator member. Thus, the positioning elements may be collapsed tothe collapsed configuration upon advancing one of the inner,intermediate, and/or outer actuator members, preferably the intermediateactuator member, to its final distal position.

In one embodiment, a closure element is associated with the elongatemember for sealing the passage. In a preferred embodiment, the closureelement is a plug member disposed on the distal end of the elongatemember. The plug member may include a thread pattern on its outersurface, and may include a distal port communicating with a passagetherethrough that, in turn, communicates with the lumen in the handledevice. A sealing member may be provided in the passage forsubstantially sealing the passage from fluid flow therethrough. The plugmember is preferably releasably attached to the distal end of theelongate member, e.g., by one or more connectors on the distal end ofthe elongate member and/or on the plug member. Alternatively, theclosure element may be a clip that is deployable from the elongatemember, e.g., from a housing slidably disposed on the elongate member. Alocator member is provided that may be inserted through the lumen, thelocator member having a distal portion that extends distally beyond thedistal end of the elongate member when the locator member is fullyinserted into the lumen. If the closure element is a plug member, thedistal portion also extends beyond the plug member, e.g., through thepassage therein. The locator member includes an elongate deflectableelement including a proximal end and a distal end, and a control elementcoupled to the distal end of the deflectable element. The controlelement is movable proximally for causing an intermediate portion of thedeflectable element, e.g., the distal portion of the locator member, tobuckle substantially transversely with respect to the longitudinal axis.In a preferred embodiment, the deflectable element is a helically woundwire and the control member is a tether extending along at least theintermediate portion of the helically wound wire. The tether may extendwithin the helically wound wire and/or along an outer surface of atleast a portion of the helically wound wire. Preferably, theintermediate portion of the deflectable element has a cross-section inits buckled configuration that is larger than a cross-section of thelumen, thereby preventing the deflectable element from being withdrawninto the plug member and/or elongate member once activated.

In another embodiment, a method is provided for sealing a passagecommunicating with a body lumen using an apparatus, such as thatdescribed above. The apparatus generally includes an elongate memberincluding proximal and distal ends, and a closure element deployablefrom the distal end of the elongate member.

A locator member is coupled to the elongate member such that a distalportion of the locator member extends beyond the distal end of thetubular member. For example, if the elongate member is an introducersheath or other tubular member including a lumen, the locator member maybe inserted into the lumen. The distal end of the elongate member isadvanced through a patient's skin towards the body lumen via the passageuntil the distal portion of the locator member is located within thebody lumen. For example, if the closure element is a plug member, theelongate member may rotated to thread the plug member into the passagetowards the body lumen.

A deflectable element on the distal portion of the locator member isbuckled from an axial collapsed configuration to a transverse expandedconfiguration. The elongate member is manipulated such that the buckleddistal portion engages or otherwise contacts a proximal wall of the bodylumen, thereby providing a tactile indication of the location of thedistal end of the elongate member relative to the body lumen.

The closure device is then deployed from the distal end of the elongatemember within the passage. The elongate member and the locator memberare then withdrawn from the passage, leaving the closure element tosubstantially seal the opening. Preferably, the deflectable element ofthe locator member includes a helically wound wire, and a tether orother control member coupled to a distal end of the helically woundwire. The tether may be subjected to tension, e.g., directed proximally,to buckle the helically wound wire substantially transversely, therebydefining the transverse configuration.

In a preferred embodiment, the closure element is a plug memberreleasably coupled to the distal end of the elongate member andincluding an external thread pattern. If the elongate member is atubular member, the plug member may include a distal port communicatingwith the lumen in the tubular member, such that the locator member maybe inserted into the tubular member until the distal portion extendsthrough the distal port of the plug member. The distal portion isinserted into the passage until the plug member enters the passage,whereupon the plug member is threaded into the passage until the distalportion of the locator member enters the body lumen. The distal portionmay be activated, as described above, and used to provide tactilefeedback to position the plug member. For example, the plug member maybe at least partially unthreaded before the plug member is deployedwithin the passage.

In an alternative embodiment, the apparatus may be used in conjunctionwith an introducer sheath or other tubular member already in placewithin the passage, e.g., that is used to access the body lumen during aprocedure. The locator member may be inserted through the tubular memberuntil the distal portion of the locator member is located within thebody lumen. The deflectable element on the distal portion of the locatormember may be buckled from an axial collapsed configuration to atransverse expanded configuration. The locator member may bemanipulated, e.g., pulled proximally, such that the buckled distalportion engages or otherwise contacts a proximal wall of the body lumen,thereby providing a tactile indication that the distal portion isdisposed within the body lumen and/or limiting further proximal movementof the locator member.

A plug member (or other closure device) may then be advanced over thelocator member into the passage. For example, the plug member, disposedon the distal end of an elongate member, may be threaded through thetissue along the passage over the locator member. Preferably, thelocator member is inserted through the distal port of the plug memberand/or through the lumen of the elongate member as the plug member isadvanced. Once the plug member attains a desired location within thepassage, the plug member may be released from the distal end of theelongate member within the passage. The distal portion of the locatormember may be returned to its axial configuration, and the elongatemember and the locator member may be withdrawn from the passage, leavingthe plug member to substantially seal the opening

To facilitate positioning of the plug member, the locator member mayinclude one or more markers, e.g., disposed on a proximal portion, thatmay have a predetermined relation with the distal portion of the locatormember. For example, the proximal portion of the locator member mayinclude a marker band located a predetermined distance from the distalportion. The elongate member may include a window for observing themarker when the plug member reaches a predetermined location relativethe distal portion, e.g., a predetermined distance proximal to thedistal portion. Alternatively, the locator member and the elongatemember may include cooperate tactile elements, e.g., tabs and pockets,that engage one another when the plug member reaches a predeterminedlocation. The plug member may then be released at the predeterminedlocation, and then the elongate member and locator member may beremoved.

Thus, the various embodiment sof the presnt invention that include anintegrated vascular introducer sheath with closure component of thepresent invention overcome disadvantages associated with previouslyknown methods and apparatus for sealing a vascular puncture by providinga quick, simple, safe, lower cost, effective, and easy-to-use solutionto wound closure. A closure device and system constructed in accordancewith the present invention provide vascular introduction and woundclosure in a single device, eliminating the time and manipulationrequired to insert a separate closure device at the completion of aprocedure. Various embodiments of such a closure device and system aredescribed in more detail below.

II. First Closure System Embodiment

Referring to FIG. 1, vascular device 10 comprises introducer sheath 12coupled to hub 14, clip housing 16, and clip actuator 18. Introducersheath 12 comprises a material typically used for vascular introducersheaths, such as polyethylene or nylon, and includes central lumen 13through which other devices may be introduced in the vasculature, forexample, to perform a diagnostic or interventional procedure such asangiography, angioplasty or stenting. Hub 14 is mounted to the proximalend of introducer sheath 12 and includes side port 20, arc-shaped lumens22, back bleed lumens 24, back bleed tubes 25, and device port 26.Device port 26 communicates with central lumen 13 of introducer sheath12, and has self-sealing elastomeric membrane 27 disposed across it.Self-sealing membrane 27, which may comprise, e.g., latex or abiocompatible synthetic rubber, permits interventional devices to beintroduced through device port 25 while preventing blood loss throughcentral lumen 13. Side port 20 of hub 14 is in communication withcentral lumen 13, and is connected to hemostatic port 34 viabiocompatible tubing 36.

Clip housing 16 includes an annular-shaped chamber that holds aelastically deformable clip. In accordance with the principles of thepresent invention, clip housing is slidably disposed on the exterior ofintroducer sheath 12 and is movable from a stowed position, adjacent hub14, to a distal clip deployment position, where the spring clip is urgedinto engagement with tissue surrounding vascular puncture.

Clip actuator 18 comprises plunger 28 and rods 30, which are configuredto slidably pass through arc-shaped lumens 22 of hub 14. The distal endsof rods 30 are mounted in clip housing 16, so that movement of plunger28 causes corresponding proximal or distal movement of clip housing 16.As described in detail hereinafter, when plunger 28 is moved to itsproximal-most position, clip housing is disposed adjacent to hub 14 andprovides adequate clearance for interventional devices to be inserteddevice port 25 and central lumen 13 into the patient's vasculature. Whenmoved to its distal-most position, plunger 28 causes rods 30 to urgeclip housing 16 distally.

Referring now also to FIG. 2, the closure component of vascular device10 is described in greater detail. Clip housing 16 comprises bore 38that slidably receives introducer sheath 12, bores 40 in which rods 30are mounted, and back bleed indicator ports 42. Back bleed indicatorports 42 are coupled to back bleed tubes 25 via lumens 44. Housing 16further comprises threaded bore 46 with male thread 48 and proximalledge 50, and clip bore 52 with proximal ledge 54. Threaded bore 46engages female thread 56 of clip expander 58. Clip expander 58 isslidably disposed on introducer sheath 12, and together with the portionof clip housing 16 surrounding the spring clip 62 forms annular chamber60.

Spring clip 62 is stored in its expanded delivery configuration inannular chamber 60 so that it slidably passes over clip expander 58until it abuts proximal ledge 54 of clip bore 52. In a deliveryconfiguration of vascular device 10, the length of annular chamber 60,as measured from the distal end of clip expander 58 to proximal ledge54, extends within the distal end of clip housing 16 for a sufficientdistance to cover the length of clip 62. In this manner, clip housing 16prevents snagging spring clip 62 from snagging on tissue duringadvancement of clip housing 16 to its deployed position, as describedhereinbelow.

Rods 30 pass through arc-shaped lumens 22 of hub 14 and mounted in bores40 of clip housing 16. Distal advancement of rods 30 causes clip housing16, expander 58, and spring clip 62 to advance distally a correspondingdistance relative to introducer sheath 12. When plunger 28 is moved toits distal-most position, rods 30 may be rotated within arc-shapedlumens 22 to rotate and advance clip housing 16 relative to clipexpander 58. This motion causes clip housing 16 to advance distallyalong female thread 56 of clip expander 58 until the proximal end of theclip expander contacts proximal ledge 50 of threaded bore 46. Furtherrotation of rods 30 causes proximal ledge 54 to urge a tissue-engagingportion of spring clip 62 distally off of clip expander 58. With cliphousing 16 positioned at a vascular puncture site P, rotation of rods 30causes the tissue-engaging portion, illustratively spikes, to pierce thevessel wall, as seen in dotted profile in FIG. 2.

In alternative embodiments, plunger 28 and rods 30 may be removablycoupled to clip housing 16, to permit unobstructed access to device port26. In this embodiment, rods 30 may include teeth that may be rotated tofixedly engage bores 40 in clip housing 16.

As discussed hereinabove, back bleed indicator ports 42 are coupled totubes 25 via blood lumens 44 that extend through clip housing 16. Backbleed tubes 25 are slidably disposed through back bleed lumens 24 of hub14. When the distal end of clip housing 16 is advanced distally againstthe vessel wall at puncture P, blood enters blood indicator ports 42 andexits tubes 25, providing visual confirmation to the surgeon that thedistal end of clip housing 16 is positioned adjacent to the vessel wall.Back bleed tubes 25 thus enable the surgeon to determine when cliphousing 16 has been advanced sufficiently to permit clip deployment,while reducing the risk that the clip is either deployed short of thepuncture site or extended into the vessel.

Still referring to FIG. 1, in conjunction with clip deployment, abioglue or tissue sealant may be delivered through hemostatic port 34,tubing 36, port 20 and central lumen 13 of introducer sheath 12 tovascular puncture P to further help seal the vessel after deployment ofclip 62. Alternatively, the bioglue or tissue sealant may be deliveredthrough the back bleed path described above.

Referring now to FIGS. 3A-3D, an illustrative spring clip 62 constructedin accordance with the principles of the present invention is describedin greater detail. FIG. 3B is a side view of the clip of FIG. 3A rotated90 degrees, wherein clip 62 is in an expanded delivery configuration.Clip 62 comprises an annular device having upper members 70 joined tolower members 72 by legs 74 to form lumen 80. Outer spikes 76 and innerspikes 78 are connected to lower members 72, and act as elongatedtissue-engaging members. Clip 62 is elastically expanded by advancingintroducer sheath 12 or clip expander 58 through lumen 80.

Upon removal of the introducer sheath, spring clip 62 resilientlyreturns to its unstressed deployed configuration, illustrated in FIGS.3C and 3D, where FIG. 3C corresponds to the view of FIG. 3A and FIG. 3Dcorresponds to the view of FIG. 3B. When removed from the exterior ofintroducer sheath 12, spring clip 62 resumes its deployed shape, inwhich the opposing sides of the clip come together until lower members72 contact one another, and outer spikes 76 cross inner spikes 78. Asdepicted in FIG. 3A, clip 62 also may optionally comprise engagementmeans 77 to securely engage the vessel being closed. Engagement means 77may, for example, comprise barbs or hooks.

Clip 62 is preferably fabricated from a superelastic material, such as anickel-titanium alloy, but may comprise any material with sufficientresilience to elastically expand for delivery over sheath 12 and fitwithin annular chamber 60 of clip housing 16. Clip 62 also may befabricated from a bioabsorbable material or a combination bioabsorbableand elastically expandable material.

FIGS. 4A and 4B illustrate an alternative embodiment of the resilientspring clip of the present invention, wherein clip 90 comprises hoop 92and opposing spikes 94. In FIG. 4A, clip 90 is depicted in theunstressed, deployed configuration, in which opposing spikes 94 contactone another, whereas in FIG. 4B clip 90 is depicted in the expanded,delivery configuration, in which opposing spikes 94 are separated by gap96. Clip 90 is elastically expanded in a manner similar to clip 62 byadvancement over introducer sheath 12, and preferably also is fabricatedfrom the materials described hereinabove.

Referring now to FIGS. 5A-5F, in conjunction with FIGS. 1-3, methods ofusing vascular device 10 are described. In FIG. 5A, introducer sheath 12has been advanced through skin, fat, and muscle tissue T into vessel V,through vascular puncture P, which is formed in accordance withwell-known techniques. With plunger 28 and rods 30 in the proximal-most,fully retracted position, an interventional procedure then is performedby introducing one or more interventional devices, e.g. angioplastyballoons, stent delivery systems, atherectomy devices, etc., throughdevice port 26 and lumen 13 of introducer sheath 12 in accordance withwell-known techniques. Side port 20 may be used to infuse fluids, e.g.,contrast agents or medications, into the vessel through introducersheath 12 during the interventional procedure.

Upon completion of the procedure, vascular device may be advantageouslyused to close vascular puncture P. At this point, clip actuator 18,housing 16, clip expander 58, and clip 62 are disposed in theproximal-most position adjacent to hub 14, as depicted in FIG. 5A.

As illustrated in FIG. 5B, clip actuator 18 then is advanced by urgingplunger 28 in the distal direction, thus causing rods 30 to slidethrough arc-shaped lumens 22 of hub 14 and advance clip housing 16.Continued distal advancement of plunger 28 causes the distal end of cliphousing 16 to abut against the exterior of the vessel, so that backbleed indicator ports 42 of clip housing 16 directly communicate withthe puncture wound. The presence of pressure in the vessel higher thanatmospheric pressure causes blood to pass through indicator ports 42,blood lumens 44, and exit through the proximal ends of tubes 25, thusconfirming that clip housing 16 is positioned at the puncture site andshould not be advanced further.

In FIG. 5C, with clip housing 16 held immobile, clip actuator 18 isrotated clockwise within arc-shaped lumens 22 so that rods 30 rotate andadvance clip housing 16 with respect to clip expander 58 (see FIG. 2).Specifically, ledge 54 of housing 16 contacts the proximal end of clip62 and drives the clip distally so that its tissue-engaging members,spikes 76 and 78, contact and pierce the wall of vessel V at pointsaround the puncture site, as discussed hereinabove with respect to FIG.2.

Once the spikes have pierced the vessel wall, clip actuator 18 isrotated counterclockwise within arc-shaped lumens 22 to retract cliphousing 16, via threaded bore 46, along clip expander 58. Thetissue-engaging members of clip 62 retain the clip within the wall ofvessel V while the housing retracts, as shown in FIG. 5D.

In FIG. 5E, with clip 62 engaged with the vessel wall, clip housing 16and clip expander 58 are withdrawn proximally by proximally withdrawingactuator 18, thereby causing clip 62 to slide off of clip expander 58.In FIG. 5E, spike 78 is embedded in tissue not shown, because thattissue lies within the plane of the cross section.

Vascular device 10 then is withdrawn from the vessel wall. Onceintroducer sheath 12 is removed from lumen 80 of clip 62, the cliprotates relative to the vessel wall, as shown in FIG. 5F, and returns toits unstressed, deployed configuration, thus drawing opposite sides ofpuncture P together to seal the puncture. At this point, a suitablebiocompatible bioglue or tissue sealant optionally may be injected intothe puncture tract, as discussed hereinabove, through device port 26 orside port, to aid in sealing vascular puncture P. Alternatively, thebioglue or tissue sealant may be delivered through the back bleed pathdescribed above.

Although preferred illustrative embodiments of the present invention aredescribed above, it will be evident to one skilled in the art thatvarious changes and modifications may be made without departing from theinvention. For example, with minor modifications, vascular device 10 maybe configured to carry spring clip 90 of FIG. 4, or any of a variety ofalternative expandable resilient clips. It is intended in the appendedclaims to cover all such changes and modifications that fall within thetrue spirit and scope of the invention. Accordingly, additionalembodiments are described below.

III. Second Closure System Embodiment

Referring to FIG. 6, a first embodiment of apparatus of a secondoperating environment the present invention is described. Vasculardevice 110 comprises introducer sheath 112 coupled to hub 114, cliphousing 116 and clip actuator 118. A closure component 120, as describedin detail hereinbelow, is disposed in clip housing 116.

Introducer sheath 112 comprises a material typically used for vascularintroducer sheaths, such as polyethylene or nylon, and includes centrallumen 113 through which other interventional devices may be introducedinto the vasculature, for example, to perform a diagnostic orinterventional procedure such as angiography, angioplasty, or stenting.

Hub 114 is mounted to the proximal end of introducer sheath 112 andincludes side port 122, actuator lumens 124, closure lumens 126, backbleed lumens 128, back bleed tubes 130, and device port 132. Device port132 communicates with central lumen 113 of introducer sheath 112, andhas self-sealing elastomeric membrane 133 disposed across it.Self-sealing membrane 133, which may comprise, e.g., latex or abiocompatible synthetic rubber, permits interventional devices to beintroduced through device port 132, while preventing blood loss throughcentral lumen 113. Side port 122 of hub 114 is also in communicationwith central lumen 113, and is connected to hemostatic port 134 viabiocompatible tubing 136.

Clip housing 116 includes two lumens, as described hereinbelow, thateach hold a bioabsorbable, deformable clip. In accordance with theprinciples of the present invention, clip housing 116 is slidablydisposed on the exterior of introducer sheath 112 and is movable from astowed position, adjacent hub 114, to a distal clip deployment position,where the bioabsorbable clip is urged into engagement with tissuesurrounding a vascular puncture. Clip housing 116 prevents the clipsfrom snagging on tissue during advancement of clip housing 116.

Clip actuator 118 comprises plunger 138 and rods 140, which areconfigured to slidably pass through actuator lumens 124 of hub 114.Plunger 138 further includes openings 139. The distal ends of rods 140are mounted in clip housing 116, so that movement of plunger 138 causescorresponding proximal or distal movement of clip housing 116. Asdescribed in detail hereinafter, when plunger 138 is moved to itsproximal-most position, clip housing 116 is disposed adjacent to hub 114and provides adequate clearance for interventional devices to beinserted through device port 132 and central lumen 113 into thepatient's vasculature. When moved to its distal-most position, plunger138 causes rods 140 to urge clip housing 116 distally.

Referring now to FIGS. 6 and 7A-7C, closure component 120 of vasculardevice 110 is described in greater detail. Clip housing 116 compriseslumen 142 that slidably receives introducer sheath 112, rod bores (notshown) in which rods 140 are mounted, clip lumens 144 in whichbioabsorbable clips 146 are housed and advanced to a puncture site, pinholes 148 for rigidly receiving distal pins 150, and back bleedindicator ports (not shown, out of the plane of the cross-section ofFIG. 7A) that are coupled to back bleed tubes 130 via blood lumens 131.

Closure component 120 further comprises caps 152 with pin holes (notshown, out of the plane of the cross-section of FIG. 7A) configured toreceive proximal pins 154, clip holders 156 attached to bioabsorbableclips 146, and locking collar drivers 158 configured to advancefasteners 160. Locking collar drivers 158 are slidably received withinlumens 139 of plunger 138, closure lumens 126 of hub 114, and cliplumens 144 of clip housing 116. Drivers 158 further comprise lumens 159and square clip bores 147, in which clip holders 156 and clips 146,respectively, are slidably received. Bores 147 are of square crosssection.

As illustrated in FIG. 7B, locking collar drivers 158 comprise proximaldriver slots 162 that communicate with lumens 159, while clip holders156 comprise proximal holder slots 164. Proximal pins 154, mounted incaps 152, pass through and are slidably received within slots 162 and164. As seen in FIG. 7C, locking collar drivers 158 further comprisedistal driver slots 166 that communicate with lumens 159, while clipholders 156 further comprise distal holder slots 168. Distal pins 150,mounted in clip housing 116, pass through and are slidably receivedwithin slots 166 and 168.

As discussed hereinabove, back bleed indicator ports (not shown) arecoupled to back bleed tubes 130 via blood lumens 131 that extend throughclip housing 1116. Back bleed tubes 130 are slidably disposed throughback bleed lumens 128 of hub 114. When the distal end of clip housing116 is advanced distally against a vessel wall at a vascular puncture,blood enters the back bleed indicator ports and exits through tubes 130,providing visual confirmation to an operator that the distal end of cliphousing 116 is positioned adjacent to the vessel wall. Back bleed tubes130 thus enable the operator to determine when clip housing 116 has beensufficiently advanced to permit clip deployment, while reducing the riskthat the clip is either deployed short of the puncture site or extendedinto the vessel.

In conjunction with clip deployment, a bioglue or tissue sealant may bedelivered through hemostatic port 134, biocompatible tubing 136, sideport 122 and central lumen 113 of introducer sheath 112 to the vascularpuncture to further help seal the vessel after deployment of clips 146.Alternatively, the bioglue or tissue sealant may be delivered throughdevice port 132 or through the back bleed path described above.

With reference now to FIGS. 8A-8C, bioabsorbable clip 146 and fastener160 are described in greater detail. FIG. 8A shows clip 146 in thedelivery configuration. Clip 146 comprises curved legs 170 and proximalend 172. Legs 170 distally terminate at spikes 174 with optionalengagement means 176, and proximally terminate at narrowed region 178.Engagement means 176 may comprise, for example, barbs or hooks. As seenin FIG. 7A, proximal end 172 attaches to clip holder 156 by, forexample, adhesive, and is slidably received by square clip bore 147 oflocking collar driver 158. As with bore 147, clip 146 is ofsubstantially square cross section.

Fastener 160 comprises bioabsorbable locking collar 180, which isslidably received on the exterior of clip 146. As seen in FIG. 8B,locking collar 180 may be distally advanced down the exterior of clip146 to deform the clip to its deployed configuration, wherein curvedlegs 170 and spikes 174 are drawn together. Clip 146 may then beseparated from clip holder 156 by rotating-proximal end 172 with respectto legs 170, causing the clip to snap into two pieces at narrowed region178, for the reasons described hereinafter. Clip 146 and locking collar180 preferably are fabricated from bioabsorbable materials, such aspolyglycolic acid.

Referring to FIGS. 9A-9B, an alternative embodiment of the closurecomponent of the present invention is described. Closure component 190comprises bioabsorbable clip 192 and fastener 194. Clip 192 comprisesproximal hoop 196 with narrowed regions 198, and legs 191 terminating inspikes 193. Fastener 194 comprises bioabsorbable wedge 195. Wedge 195has a diameter substantially equal to the diameter of hoop 196 at itsdistal end, the diameter tapering to a maximum diameter at the proximalend of wedge 195. Clip 192 therefore may be deformed from the deliveryconfiguration of FIG. 9A to the deployed configuration of FIG. 9B,wherein legs 191 and spikes 193 are drawn together, by advancing wedge195 into hoop 196 to deform clip 192 at narrowed regions 198. Lumen 197extends through hoop 198 of clip 192, while lumen 199 extends throughwedge 196. Clip 192 and wedge 196 therefore are configured for deliveryover the exterior of an introducer sheath. The clip and wedge preferablyare fabricated from bioabsorbable materials.

With reference to FIGS. 10A-10B through 13A-13B, methods of usingvascular device 110 are described in connection with FIGS. 6-9B.Introducer sheath 112 is advanced through skin, fat, and muscle tissueinto vessel V, through vascular puncture P, which is formed inaccordance with well-known techniques. Vascular device 110 is used inthe same manner as a standard introducer sheath, with instruments beingadvanced into the vessel via lumen 113. Specifically, with plunger 128and rods 140 in the proximal-most, fully retracted position, aninterventional procedure then is performed by introducing one or moreinterventional devices, e.g. angioplasty balloons, stent deliverysystems, atherectomy devices, etc., through device port 132 and lumen113 of introducer sheath 112 in accordance with well-known techniques.Side port 122 may be used to infuse fluids, e.g., contrast agents ormedications, into the vessel through introducer sheath 112 during theinterventional procedure.

Upon completion of the procedure, vascular device 110 advantageously maybe used to close vascular puncture P. At this point, clip actuator 118,clip housing 116, and closure component 120 with clips 146, are disposedin the proximal-most position adjacent to hub 114.

Clip actuator 118 then is advanced by urging plunger 138 in the distaldirection, thus causing rods 140 to slide through actuator lumens 124 ofhub 114 and advance clip housing 116. Distal pins 150, mounted inhousing 116, abut distal slots 166 and 168 of drivers 158 and holders156, respectively. Thus, distal advancement of clip housing 116 alsodistally advances closure component 120. Continued distal advancement ofplunger 138 causes the distal end of clip housing 116 to abut againstthe exterior of the vessel, so that the back bleed indicator ports (notshown) of clip housing 116 directly communicate with the puncture wound.The presence of pressure in the vessel higher than atmospheric pressurecauses blood to pass through the indicator ports, through blood lumens131, and exit through the proximal ends of tubes 130, thus confirmingthat clip housing 116 is positioned at the puncture site and should notbe advanced further.

FIG. 10B illustrates closure component 120 via sectional views throughclip housing 116 along planes parallel to introducer sheath 112. FIG.10A shows the locations of proximal pins 154 within proximal slots 162and 164, and the locations of distal pins 150 within distal slots 166and 168, corresponding to the relative longitudinal positions of clipholders 156 and locking collar drivers 158 depicted in FIG. 10B. Pinlocations are shown via side views of clip holders 156 and lockingcollar drivers 158 at the relevant locations.

As seen in FIGS. 10A and 10B, with clip housing 116 positioned atpuncture site P, proximal pins 154, mounted in caps 152, are positionedat the extreme right of proximal driver slots 162 and of thecircumferential portions of proximal holder slots 164. Distal pins 150are located at the distal end of distal driver slots 166 and of thelongitudinal portions of distal holder slots 168.

In FIGS. 11A and 11B, with clip housing 116 held immobile, force isapplied to caps 152 to distally advance clips 146 with respect tohousing 116. Specifically, proximal pins 154 abut and apply forceagainst proximal slots 162 and 164, which advances drivers 158 and clipholders 156, as well as attached clips 146 and locking collars 180.Distal pins 150 move freely within distal slots 166 and the longitudinalportions of distal slots 168. Distal advancement of clips 146 continuesuntil pins 150 abut against the proximal end of the longitudinalportions of distal holder slots 168 of clip holders 156. Drivers 158likewise are restrained by their connection to clip holders 156 viaproximal pins 154. The tissue-engaging members, spikes 174 andengagement means 176, of clips 146 contact and pierce the wall of vesselV on opposite sides of the puncture site P.

As seen in FIGS. 12A and 12B, once the spikes have pierced the vesselwall, locking collar drivers 158 are advanced distally while cliphousing 116 and clip holders 156 remain stationary, thereby distallyadvancing locking collars 180 down the exteriors of clips 146 to drawlegs 170 and spikes 174 together to close puncture P. Engagement means176 serve to retain the clips within the vessel wall during healing.

To achieve this advancement of drivers 158 with respect to clip holders156, caps 152 are rotated clockwise, as viewed from above, untilproximal pins 154 abut against the extreme left of proximal slots 162and 164, thereby aligning the pins with the longitudinal portions ofproximal holder slots 164. Then, force is once again applied to caps 152to advance drivers 158 and deform clips 146 to their deployedconfigurations. Specifically, proximal pins 154 abut and apply force toproximal driver slots 162, thereby distally advancing drivers 158. Pins154 move freely within the longitudinal portions of proximal holderslots 164 until they abut against the distal ends of slots 164.Likewise, distal driver slots 166 move freely until distal pins 150 abutthe proximal ends of slots 166. In FIG. 12A, when proximal pins 154 abutslots 164 and distal pins 150 abut slots 166, locking collars 180 havebeen driven down the exteriors of clips 146, thereby deforming the clipsto draw legs 170 together and close the puncture site.

In FIGS. 13A and 13B, with clips 146 deformed to seal puncture P, clipholders 156 are detached from clips 146 by snapping the clips free atnarrowed regions 178. At this point, or prior to detachment, a suitablebiocompatible bioglue or tissue sealant optionally may be injected intothe puncture tract, as discussed hereinabove, through device port 132 orside port 122, to aid in sealing vascular puncture P. Alternatively, thebioglue or tissue sealant may be delivered through the back bleed pathdescribed above. Vascular device 110 then is withdrawn from the vesselwall, completing the procedure.

Clips 146 are detached from clip holders 156 by rotating caps 152counterclockwise, as viewed from above. Proximal pins 154 of caps 152move freely within proximal driver slots 162, but abut against thedistal end of the longitudinal portions of proximal holder slots 164 andcause clip holders 156 to rotate with respect to collar drivers 158.Distal pins 150 of clip housing 116 move freely within thecircumferential portions of distal holder slots 168 during rotation ofclip holders 156. Meanwhile, drivers 158 are restrained from rotation bydistal pins 150, which abut against distal driver slots 166.Bioabsorbable clips 146 do not rotate because the square cross sectionof square clip bores 147 of drivers 158 matches the substantially squarecross section of clips 146; thus, since drivers 158 are restrained fromrotation, so are clips 146. Non-square cross sections for clips 146 andbores 147, capable of performing the restraining function, will beapparent to those of skill in the art and fall within the scope of thepresent invention.

Since clips 146 are restrained while clip holders 156 rotate, and sinceproximal ends 172 of clips 146 are attached to clip holders 156,counterclockwise rotation of caps 152 causes clips 146 to snap at theirweakest points: narrowed regions 178. Vascular device 110 may then beremoved from the patient to complete the procedure.

Although preferred illustrative embodiments of the present invention aredescribed above, it will be evident to one skilled in the art thatvarious changes and modifications may be made without departing from theinvention. For example, with minor modifications, vascular device 110may be configured to carry closure component 190 of FIG. 10A, or any ofa variety of alternative bioabsorbable and deformable clips. Proximalpins 154 may be formed integrally with caps 152, and distal pins 150 maybe formed integrally with clip housing 116. Any number of clips 146 maybe used to close the vascular puncture. It is intended in the appendedclaims to cover all such changes and modifications that fall within thetrue spirit and scope of the invention.

IV. Third Closure System Embodiment

Referring to FIG. 14, a first embodiment of an apparatus of the thirdoperating environment in accordance with present invention is described.Vascular device 210 comprises sheath 212 coupled to hub 214, closurecomponent 216, and closure actuator 218.

Sheath 212, which may, for example, comprise an introducer sheath, atrocar, or a catheter, includes central lumen 213 through which otherdevices may be introduced into the vasculature, for example, to performa diagnostic or interventional procedure such as angiography,angioplasty, or stenting, or to seal a puncture site.

Hub 214 is mounted on the proximal end of sheath 212 and includes sideport 220, arc lumens 222, and device port 224. Device port 224communicates with central lumen 213 of sheath 212, and has self-sealingelastomeric membrane 225 disposed across it. Self-sealing membrane 225,which may comprise, for example, latex or a biocompatible syntheticrubber, permits interventional devices to be introduced through deviceport 224, while preventing blood loss through central lumen 213. Sideport 220 of hub 214 is also in communication with central lumen 213, andis connected to hemostatic port 226 via biocompatible tubing 228.

In accordance with the principles of the present invention, closurecomponent 216 comprises lumen 230 that receives sheath 212. Component216 is slidably disposed on the exterior of sheath 212 and is movablefrom a stowed position, adjacent hub 214, to a distal deploymentposition, where tines 217 of component 216 are urged into engagementwith tissue surrounding a vascular puncture. Closure component 216comprises at least two sharpened tips, or tines 217. Tines 217preferably comprise back bleed ports 232. Closure component 216 isrotatable within arc-lumens 222 about the longitudinal axis of sheath212, so that, with tines 217 engaging tissue surrounding the vascularpuncture, component 216 closes the puncture.

Closure actuator 218 comprises plunger 234 and tubes 236, which areconfigured to slidably pass through arc lumens 222 of hub 214. Theproximal ends of tubes 236 are coupled to back bleed bores 238 ofplunger 234. The distal ends of tubes 236 are mounted, eitherpermanently or detachably, in closure component 216, so that movement ofplunger 234 causes corresponding proximal or distal movement of closurecomponent 216. Likewise, rotation of plunger 234 causes correspondingrotation of tubes 236 within arc lumens 222, which, in turn, rotatesclosure component 216 about the longitudinal axis of sheath 212.

Plunger 234 further comprises device bore 240, coaxially aligned withdevice port 224, and through which interventional devices or puncturesealants may be passed. As described in detail hereinafter, when plunger234 is moved to its proximal-most position, closure component 216 isdisposed adjacent to hub 214 and preferably provides adequate clearancefor interventional devices to be inserted through device port 224 andcentral lumen 213 into the patient's vasculature. When moved to itsdistal-most position, plunger 234 causes tubes 236 to urge closurecomponent 216 distally. Interventional devices or sealants then may beintroduced through device bore 240, device port 224, and central lumen213 into the vasculature.

Back bleed bores 238 of plunger 232 are in communication with back bleedlumens (not shown) within tubes 236. The back bleed lumens of tubes 236are in communication with back bleed ports 232 of tines 217, therebyestablishing a complete back bleed path through ports 232, the lumens(not shown) of tubes 236, and bores 238. When tines 217 of closurecomponent 216 pierce a vessel wall surrounding a vascular puncture,blood enters back bleed ports 232 and exits through back bleed bores238, providing visual confirmation to a surgeon that tines 217 arepositioned within the vessel wall. The back bleed path thus enables thesurgeon to determine when closure component 216 has been sufficientlyadvanced to permit rotation of component 216 to close the puncture,while reducing the risk that component 216 is either short of thepuncture site or is extended into the vessel.

In conjunction with closure of the puncture site caused by rotation ofcomponent 216, a puncture sealant may be introduced to the puncture siteto seal the site closed. The sealant may, for example, comprise anadhesive, such as a bioglue, tissue sealant, or clotting agent,delivered through hemostatic port 226, biocompatible tubing 228, sideport 220 and central lumen 213 of introducer sheath 212 to the vascularpuncture to further help seal the vessel after puncture closure withclosure component 216. Alternatively, the adhesive may be deliveredthrough device port 224 or through the back bleed path described above.Instead of adhesives, the closure component may further comprise thesealant, wherein the closure component is left in place within thevessel until hemostasis naturally occurs. The sealant may also comprisesutures delivered through central lumen 213. Additionally, the sealantmay comprise thermal energy application from, for example, electricalinduction, infrared light, ultrasonic vibration, microwave or laserirradiation, and other means.

With reference to FIG. 15, an alternative puncture sealing device inaccordance with the present invention is described. Sealing device 250comprises delivery device 252 and clip 254. Delivery device 252comprises proximal end 256 attached to tube 258. Tube 258 terminates atfirst jaw 260 at its distal end and further comprises lumen 262 and pin264. Pin 264 extends into lumen 262 from an interior surface of tube 258and is disposed perpendicular to the longitudinal axis of tube 258.

Delivery device 252 further comprises second jaw 266 having femaleconnector 268 coupled to pin 264, so that second jaw 266 pivots aboutpin 264. Second jaw 266 further comprises moment arm 270. Tension spring272 is coupled to moment arm 270 and to the interior surface of tube 258in a manner that biases second jaw 266 against first jaw 260.

First jaw 260 and second jaw 266 preferably form channel 274 when biasedagainst one another. Channel 274 is configured to receive clip 254. Thebiasing force applied by tension spring 272 holds clip 254 withinchannel 274, so that the clip may be advanced into tissue surrounding avascular puncture that has had its edges approximated by closurecomponent 216.

Delivery device 252 still further comprises plunger 276 coupled topushrod 278 having release arm 280. Pushrod 278 is received within lumen262 of tube 258, so that release arm 280 engages moment arm 270.

Distal advancement of pushrod 278, via application of force to plunger276, causes release arm 280 to urge moment arm 270 distally. This motionovercomes the biasing force applied by tension spring 272 and causessecond jaw 266 to pivot about pin 264. Second jaw 266 thus no longercontacts first jaw 260, and clip 254 is released from channel 274. Tube258, first jaw 260, second jaw 266, and clip 254 of sealing device 250preferably are sized for introduction into a patient's vasculaturethrough device bore 240, device port 224, and lumen 213 of vasculardevice 210.

Referring to FIGS. 16A-16B through 19A-19B in conjunction with FIGS. 14and 15, a method of using vascular device 210 with sealing device 250 isdescribed. Sheath 212 is advanced through skin, fat, and muscle tissueinto vessel V, through the vessel wall tissue surrounding vascularpuncture P. With plunger 234 and tubes 236 of actuator 218 in theproximal-most, fully retracted position, an interventional procedure isperformed by introducing one or more interventional devices, e.g.angioplasty balloons, stent delivery systems, atherectomy devices, etc.,through device port 224 and lumen 213 of sheath 212, in accordance withwell-known techniques. Side port 220 may be used to infuse fluids, e.g.,contrast agents or medications, into the vessel through sheath 212during the interventional procedure.

Upon completion of the procedure, vascular device 210 may beadvantageously used to close vascular puncture P. At this point, closureactuator 218 and closure component 216 are disposed in the proximal-mostposition, with component 216 adjacent to hub 214. Closure actuator 218is advanced by urging plunger 234 in the distal direction, thus causingtubes 236 to slide through arc lumens 222 of hub 214 and advance closurecomponent 216.

As seen in FIG. 16A, continued distal advancement of plunger 234 causestines 217 at the distal end of closure component 216 to pierce tissuesurrounding puncture P, so that the back bleed ports 232 of tines 217directly communicate with the puncture wound. Tine punctures T in FIG.16B represent the points at which tines 217 enter vessel V. The presenceof pressure in the vessel higher than atmospheric pressure causes bloodto pass through back bleed ports 232, through the back bleed lumens (notshown) of tubes 236, and exit through the proximal ends of back bleedbores 238, thus confirming that tines 217 have engaged tissue around thepuncture site and should not be advanced further.

In FIG. 17A, sheath 212 is removed from puncture P to facilitate closureof LuHP the puncture. Closure actuator 218 is held stationary while hub214 is withdrawn proximally, thereby withdrawing sheath 212 proximallyfrom puncture P. The puncture remains open, as seen in FIG. 17B. Withsheath 212 no longer within puncture P, closure actuator 218 is rotatedwithin arc lumens 222 to rotate closure component 216. Rotation ofclosure component 216 causes tines 217 to rotate and urge the punctureclosed, as seen in FIGS. 18A and 18B.

Upon closure of puncture P, a sealant is introduced to seal the woundclosed. The sealant may, for example, comprise an adhesive, such as abioglue, tissue sealant, or clotting agent, it may comprise a suture, itmay comprise thermal energy application, or it may comprise leaving theclosure component in place within vessel V until hemostasis naturallyoccurs. Alternatively, the sealing device may comprise a clip, asdescribed hereinafter.

FIGS. 18A and 19A show apparatus 210 used in conjunction with sealingdevice 250 of FIG. 15. With clip 254 disposed in channel 274 of deliverydevice 252, the delivery device is delivered to vessel V through devicebore 240 of closure actuator 218, device port 224 of hub 214, andcentral lumen 213 of sheath 212. Clip 254 punctures the vessel at tissuesurrounding closed puncture P, creating clip punctures C and sealing thepuncture. Pushrod 278 of delivery device 252 is then actuated toseparate second jaw 266 from first jaw 260 to release clip 254 fromdelivery device 252. Apparatus 210 and delivery device 252 are removedfrom the patient to complete the procedure. Clip 254 maintains closureuntil hemostasis occurs and is preferably bioabsorbable so that noforeign materials are permanently implanted in the patient's body.Additional clips may also be implanted, as required.

With reference now to FIGS. 20A-20C, an alternative integrated vasculardevice in accordance with the present invention is described. Apparatus300 comprises sheath 302 coupled to hub 304, closure component 306, andclosure actuator 308.

The sheath 302 may, for example, comprise an introducer sheath, atrocar, or a catheter, and includes central lumen 303 through whichother devices may be introduced into the vasculature, for example, toperform a diagnostic or interventional procedure such as angiography,angioplasty, or stenting, or to seal a puncture site. Hub 304 comprisesbore 310, which slidably receives actuator 308, and device port 312,which is in communication with central lumen 303 of sheath 302 andpermits introduction of interventional devices while preventing bloodloss through central lumen 303. Hub 304 further comprises side port 314.

Closure component 306 comprises outer housing 316 having lumen 318configured to slidably receive sheath 302, bore 320 for slidablyreceiving inner housing 322, lumen 324 adapted to receive closureactuator 308, and needles or prongs 326 with sharpened tips 328. Innerhousing 322 has lumen 323 adapted to receive sheath 302 and channels 330adapted to receive prongs 326. Component 306 comprises at least twoprongs 326, and preferably comprises four.

Closure actuator 308 comprises actuation tube 332 having lumen 333,actuation rod 334 disposed within actuation tube 332, first plunger 336coupled to the proximal end of tube 332, and second plunger 338 coupledto the proximal end of rod 334. The distal end of tube 332 is affixed,either permanently or detachably, in lumen 324 to outer housing 316 ofclosure component 306, while the distal end of rod 334 is coupled toinner housing 322.

To perform an interventional procedure through central lumen 303 ofsheath 302, the sheath is advanced through skin, fat, and muscle tissueinto vessel V, through vascular puncture P, in accordance withwell-known techniques. With closure component 306 in the proximal-most,fully retracted position adjacent hub 304, the interventional procedurethen is performed by introducing one or more interventional devices,e.g. angioplasty balloons, stent delivery systems, atherectomy devices,etc., through device port 312 and lumen 303 of sheath 302, again inaccordance with well-known techniques. Side port 314 may be used toinfuse fluids, e.g., contrast agents or medications, into the vesselthrough sheath 302 during the interventional procedure.

Upon completion of the procedure, apparatus 300 advantageously may beused to close the vessel. Closure component 306 is advanced distally byurging plungers 336 and 338 distally. Inner housing 322 is onlypartially received within bore 320 of outer housing 316 so that prongs326 are elastically deformed and received within channels 330. As shownin FIG. 20A, closure component 306 is advanced until inner housing 322abuts against the vessel V, as may be determined, for example, with aback bleed indicator (not shown).

In FIG. 20B, first plunger 336 is urged distally to distally advanceactuation tube 332 and outer housing 316, while second plunger 338 andsheath 302 are held stationary. Advancement of outer housing 316advances sharpened tips 328 of prongs 126 into tissue surroundingpuncture P.

In FIG. 20C, sheath 302 and second plunger 338 are retracted proximallyto draw sheath 302 out of vessel V and to draw inner housing 322completely within bore 320 of outer housing 316. Proximally retractinginner housing 322 via actuation rod 334 and second plunger 338 removesprongs 326 of outer housing 316 from channels 330 of the inner housing.The prongs resiliently contract to a lower stress configuration, therebydrawing opposing sides of puncture P together and closing the wound. Asealant may then be introduced to the closed puncture to seal the siteclosed, as discussed hereinabove. Alternatively, the sealing device maycomprise RF current, supplied by an generator (not shown), appliedacross opposed tips 328, which act as bipolar electrodes.

Referring to FIGS. 21A-21E, as well as FIGS. 22A and 22B, a stillfurther alternative embodiment of apparatus of the present invention isdescribed. FIGS. 21A-21E depict the closure component of an integratedvascular device in use at vascular puncture P within vessel V. Apparatus350 comprises sheath 352 coupled to a hub (not shown), closure component354, and a closure actuator (not shown). Various closure actuators foruse with closure component 354 will be apparent to those of skill in theart from the foregoing embodiments.

Sheath 352 may, for example, comprise an introducer sheath, a trocar, ora catheter, and includes central lumen 353 through which other devicesmay be introduced into the vasculature, for example, to perform adiagnostic or interventional procedure such as angiography, angioplasty,or stenting, or to seal a puncture site. Closure component 354 comprisesspacer 356, needles 358, and needle cover 360. Spacer 356 is coaxiallyand slidably disposed about the exterior of sheath 352, and preferablyhas an annular diameter of about 1 mm to ensure that needles 358 engagethe tissue surrounding puncture P rather than enter the puncture, sothat the needles are able to draw the wound closed, as describedhereinbelow. Needles 358 are disposed between spacer 356 and cover 360during advancement to puncture P. Needles 358 comprise ledges 362, whichact as positive stops to prevent excessive advancement of the needleswith respect to cover 360, which comprises corresponding annular ledge364. Cover 360 further comprises elastic segment 366, configured toelastically deform needles 358. Closure component 354 comprises at leasttwo needles 358, and preferably comprises four. Needles 358 may furthercomprise retaining means (not shown), such as barbs or hooks, to assistin gripping tissue.

As shown in FIG. 21A, sheath 352 may be advanced through skin, fat, andmuscle tissue into vessel V, through vascular puncture P, in accordancewith well-known techniques. With closure component 354 in aproximal-most, fully retracted position adjacent the hub, aninterventional procedure is performed through central lumen 353 ofsheath 352 by introducing one or more interventional devices through thelumen into the patient's vasculature. Closure component 354 then isadvanced via the closure actuator until it abuts against vessel V, asmay be determined, for example, with a back bleed indicator, such asdescribed for the foregoing embodiments. Cover 360 protects needles 358and prevents snagging of tissue as closure component 354 is distallyadvanced down sheath 352 and through skin, fat, and muscle tissue.Spacer 356 retains needles 358 in a position away from the edge ofpuncture P.

In FIG. 21B, needles 358 are distally advanced with respect to needlecover 360 until ledge 362 abuts ledge 364. Needles 358 deflect elasticsegment 366 of cover 360 outward and pierce tissue surrounding punctureP. FIG. 22A depicts, in isometric view, the segment of vessel Vsurrounding puncture P. With a needle arrangement comprising fourneedles 358, the needles create needle punctures N surrounding vascularpuncture P. Sheath 352 and spacer 356 then are retracted proximally andremoved from vessel V, as shown in FIG. 21C. As depicted in FIGS. 21Cand 21D, elastic segment 366 of needle cover 360 resiliently contracts,thereby drawing needles 358 together and approximating the edges of thewound.

A sealant, such as a bioglue, tissue sealant, or clotting agent, thenmay be introduced to the puncture site to seal the wound closed.Alternatively, closure component 354 may be maintained in position untilhemostasis occurs naturally, or sutures may be introduced throughcentral lumen 353. In addition, or in the alternative, RF energy may beapplied across needles 358 or a clip, such as clip 254 of sealing device250 of FIG. 15, may be applied. Thermal energy from electricalinduction, infrared light, ultrasonic vibration, microwave or laserirradiation, and other means may also be used to seal the puncture.

Illustratively, FIG. 21E depicts sealing device 370, comprising adhesive372, being delivered through central lumen 353 within delivery sheath374. After sufficient time for adhesive 372 to set, apparatus 350 isremoved from vessel V.

V. Fourth Closure System Embodiment

Turning now to FIGS. 23-24, which show a first preferred embodiment ofan apparatus 410 for providing access into a blood vessel or other bodylumen from an incision, puncture, or other passage (not shown in FIGS.23 and 24), and/or for delivering a closure element, such as clip 426(shown in phantom), for closing the passage. Generally, the apparatus410 includes an introducer sheath 412, a housing 424 slidably disposedon the sheath 412, a locator member 414 insertable into the sheath 412,and an housing actuator assembly 430.

The sheath 412 includes a substantially flexible or semi-rigid tubularbody 415 including a lumen 416 extending between its proximal and distalends 418, 420. The distal end 420 has a size and shape to facilitateinsertion into a blood vessel, e.g., having a tapered tip 422 forfacilitating substantially atraumatic introduction through the passageand at least partially into the vessel. The lumen 416 has a size foraccommodating insertion of one or more devices therethrough, such as acatheter, guidewire, and the like (not shown). The sheath 412 alsopreferably includes a seal (not shown), such as a hemostatic valve,within the lumen 416 at or near the proximal end 418 that provides afluid-tight seal, yet accommodates insertion of one or more devices,such as the locator 414, into the lumen 416 without fluid passingproximally from the sheath 412.

Optionally, the sheath 412 may include a side port 419 that communicateswith the lumen 416, for example, to allow the infusion of fluids intothe lumen 416, through the sheath 412. Alternatively, or in addition,the side port 419 may be used to provide a “bleed back” indicator, suchas that disclosed in U.S. Pat. No. 6,626,918, entitled “Apparatus andMethods for Positioning a Vascular Sheath,” which is assigned to theassignee of the present invention. The disclosure of this patent and anyreferences cited therein are expressly incorporated herein.

A housing 424 is slidably disposed on an exterior of the sheath 412, thehousing 424 configured for releasably holding the closure element 426.The housing 424 may include an ejector or other mechanism (not shown)for deploying the closure element 426 from the housing 424. In apreferred embodiment, the closure element 426 is an annular-shaped clip,including one or more barbs 428 for engaging the tissue around thepuncture adjacent to the wall of the vessel. Preferably, the clip 426 isconfigured for drawing the tissue around the puncture at the wall of thevessel substantially closed and/or for enhancing hemostasis within thepuncture. Exemplary embodiments of a housing and closure element for usewith an apparatus in accordance with the present invention are disclosedU.S. Pat. Nos. 6,197,042, 6,461,364, and 6,391,048, which are expresslyincorporated herein by reference.

The housing 424 is actuable from the proximal end 418 of the sheath 412(FIG. 23), for example, by housing actuator assembly 430, for advancingthe closure element 426 distally during deployment. The housing 424 maybe substantially permanently but slidably disposed on the sheath 412. Inthis embodiment, the housing actuator assembly 430 may be substantiallypermanently attached to the proximal end 418 of the sheath 412. Thehousing 424 may be coupled to the housing actuator assembly 430 suchthat the housing 424 may be directed axially along the exterior of thesheath.

Alternatively, the housing 424 may be provided separate from the sheath412 (not shown), e.g., with the closure element 426 preloaded therein.In this embodiment, the housing actuator assembly 430 may also beprovided separate from the sheath 412, as shown, either coupled to orseparate from the housing 424. Any time before delivering the closureelement 426, the housing 424 may be directed over the sheath 412, e.g.,by inserting the proximal end 418 of the sheath 412. The housingactuator assembly 430 may be attached to the proximal end 418 of thesheath 412, e.g., by cooperating connectors (not shown). The housing 424may be coupled to the housing actuator assembly 430, if not alreadyattached, thereby preparing the housing 424 for use.

In a preferred embodiment shown in FIGS. 23 and 24, the housing actuatorassembly 430 includes first and second actuator members 446, 448 thatare generally movable with respect to one another. The first actuatormember 446 may be connected to the proximal end 418 of the sheath 412,for example, by rods (not shown) such that the first member 446 issubstantially fixed with respect to the sheath 412. A rod, cable, orother control wire 444 is coupled to and extends generally proximallyfrom the housing 424. The control wire 444 may extend along an outersurface of the sheath 412, as shown, or alternatively may extend througha lumen (not shown) in the sheath 412 beyond the proximal end 418.

A loose end 450 of the control wire 444 may be coupled to the secondactuator member 448. For example, the housing actuator assembly 430 maybe advanced over the control wire 444 such that the loose end 450 passesthrough aperture 452 in the first member 446 and is received in a matingpocket 454 in the second member 448, as best seen in FIG. 24. The looseend 450 may be frictionally engaged within the pocket 454 or,alternatively, the loose end 450 and pocket 454 may include cooperatingdetents (not shown) for securing the control wire 444 to the secondactuator member 448.

The second actuator member 448 may be movable with respect to the firstactuator member 446 by one or more rods or rails (not shown) extendingtherebetween. Thus, the second actuator member 448 may be movable from afirst or proximal position (not shown), located a first distance fromthe first actuator member 446, distally to a second or distal position(shown in FIG. 24), located a second closer distance from the firstactuator member 446. When the housing actuator assembly 430 is attachedto the sheath 412 with the control wire 444 coupled to the secondactuator member 448, the housing 424 may be directed from a proximalposition (e.g., shown in FIG. 23) to a distal or delivery position(e.g., shown in FIG. 24) when the second actuator member 448 is movedfrom its proximal position to its distal position.

In a preferred embodiment, the second actuator member 448 is biased toits distal position, for example, by spring 456 or other biasingelement. The second actuator member 448 may be locked in its proximalposition, for example, by a locking mechanism (not shown), therebyretaining the housing 424 in its proximal position. When it is desiredto advance the housing 424, a button, switch, or other activation member(not shown) may be deployed to release the locking mechanism, therebyautomatically directing the second actuator member 448 towards the firstactuator member 446, and thereby advancing the housing 424 to its distalposition, as described further below. The closure element 426 may beautomatically ejected from the housing 424 once it reaches the distalposition or the closure element 426 may be subsequently ejected by aseparate action. It will be appreciated by those skilled in the art thatother housing actuator configurations may be provided for advancing thehousing 424 with respect to the sheath 412, e.g., to deliver the closureelement 426.

The housing actuator assembly 430 may also include an adjustmentmechanism, such as threaded bolt or knob 458. For example, the knob 458may be provided on the first actuator member 446 such that, as the knob458 is rotated, the first actuator member 446 may be moved axially withrespect to the sheath 412. Because the first actuator member 446 may beadjusted distally or proximally with respect to the sheath 412, thedistal position of the second actuator member 448 consequently may beadjusted. This, in turn, may facilitate adjusting the distal position ofthe housing 424, e.g., to compensate for the thickness of a particularwall of a blood vessel when a closure element 426 is delivered to closea puncture in the wall.

Turning to FIGS. 23, 24, 25A, and 25B, the locator member 414 includes aflexible or semi-rigid tubular body or other elongate rail 432 having aproximal end 434 and a distal end 436. An actuator rod or other elongatemember 438 is slidably disposed with respect to the rail 432, e.g.,within a lumen 433 of tubular body 432. Preferably, the locator member414 includes an annular ridge 440 or other detent on or near itsproximal end 440 that may engage a complementary-shaped pocket 442 orother cooperating detent on the sheath 412. Thus, the locator member 414may be substantially secured axially with respect to the sheath 412.

As best seen in FIGS. 25A and 25B, a distal portion 460 of the locatormember 414 includes a substantially rounded, soft, and/or flexibledistal tip 462, possibly including a pigtail (not shown) that mayfacilitate atraumatic advancement of the distal portion 460 into a bloodvessel or other body lumen. The locator member 414 preferably has alength relative to the sheath 412 such that the distal portion 460extends beyond the distal end 420 of the sheath 412 when the locatormember 414 is fully received therein, as shown in FIG. 24.

One or more, and preferably a plurality of, positioning elements 464 areprovided on the distal portion 460 that may be selectively expandablebetween a substantially axial collapsed configuration (shown in FIG.25A) and a substantially transverse expanded configuration (shown inFIG. 25B). Preferably, the positioning elements 464 are substantiallyflexible splines configured for expanding substantially transverselywith respect to a longitudinal axis 413 of the apparatus 410. In oneembodiment, shown in FIGS. 23 and 24, the locator member 414 includes apair of splines 464 disposed generally opposite one another about thedistal portion 460. Alternatively, as shown in FIG. 28, the locatormember 414 may include four splines 464 that are substantially equallyspaced about the distal portion 460. The locator member 414 may includemore or fewer splines without deviating from the scope of the presentinvention.

Optionally, the splines 464 may include radiopaque markers (not shown)or may be at least partially formed from radiopaque material tofacilitate observation of the splines 464 using fluoroscopy or otherimaging systems. In addition, the housing 424 may include a radiopaquemarker, e.g., at its distal end (not shown) and/or the closure element426 may include a radiopaque marker or may be made from radiopaquematerial. This may facilitate monitoring the relative location of theclosure element 426 to the splines 464, as described further below.

Returning to FIGS. 25A and 25B, each spline 464 preferably has a firstfixed (e.g., proximal) end 464 a and a second movable (e.g., distal) end464 b. The second end 464 b may be axially movable towards the first end464 a to cause an intermediate region 464 c of the spline 464 to expandtransversely outward, thereby defining the substantially transverseexpanded configuration. In a preferred embodiment, actuator rod 438extends through the distal portion 460 and is coupled to the second end464 b of the splines 464 and/or to distal tip 462 of the locator member414. The rod 438 may be moved axially, e.g., proximally, with respect tothe rail 432 to selectively expand the splines 464 between theircollapsed configuration and their expanded configuration.

A locator actuator 470 may be coupled to the locator member 414, thelocator actuator 470 configured for selectively expanding the splines464 from their collapsed configuration to their expanded configuration.For example, the locator actuator 470 may include a switch 472 that maybe depressed or rotated to retract or move the rod 438 proximally,thereby expanding or deploying the splines 464. The locator actuator 470preferably includes a lock (not shown) for securing the rod 438 in aproximal position and thereby locking the splines 464 in their expandedconfiguration. The lock may be released, for example, by depressing theswitch 472. The locator actuator 470 may include a spring 474 or otherbiasing mechanism for biasing the rod 438 distally, e.g., to return thesplines 464 to their collapsed configuration when the lock is released.For example, as described further below, the lock may be released uponactivation of the housing actuator assembly 430, e.g., when the secondactuator member 448 moves towards its distal position.

Turning to FIGS. 26A-26F, the apparatus 410 may be used to provideaccess into a blood vessel or other body lumen 490. Preferably, theapparatus 410 may be used to deliver a closure device, such as clip 426,to close and/or seal an incision, puncture, or other passage 492 thatextends from a patient's skin 494 through intervening tissue 496, and awall 498 of the vessel 490.

As shown in FIGS. 26A-26B, the sheath 412, without the locator member414 therein, may be inserted or otherwise positioned within the bloodvessel 490, i.e., through the passage 492. The sheath 412 is preferablyprovided with the housing 424 in its proximal position, without thehousing actuator assembly (not shown) attached. Alternatively, thehousing actuator assembly may be provided attached to the sheath 412 aslong as the lumen 416 may be accessed. In a further alternative, thesheath 412 may be provided without the housing 424 thereon. The sheath412 may be advanced over a guide wire or other rail (not shown)previously positioned through the passage 492 into the blood vessel 490using a conventional procedure. Preferably, the blood vessel 490 is aperipheral vessel, such as a femoral or carotid artery, although otherbody lumens may be accessed using the sheath 412, as will be appreciatedby those skilled in the art.

The passage 492, and consequently the sheath 412, may be oriented at asubstantially acute angle alpha (“α”) with respect to the vessel 490,thereby facilitating introduction of devices through the lumen 416 ofthe sheath 412 into the vessel 490 with minimal risk of damage to thevessel 490. One or more devices, such as a guide wire, a catheter, andthe like (not shown), may be inserted through the sheath 412 andadvanced to a desired location within the patient's body. For example,the devices may be used to perform a therapeutic or diagnosticprocedure, such as angioplasty, atherectomy, stent implantation, and thelike, within the patient's vasculature.

After the procedure is complete, the device(s) may be removed from thesheath 412, and the locator member 414 may be inserted through thehemostatic valve (not shown) into the lumen 416. If the housing 424 isnot already provided on the sheath 412, the housing 424 and/or thehousing actuator assembly (not shown) may be advanced over or otherwiseattached to the proximal end of the sheath 412, preferably before thelocator member 414 is inserted into the sheath 412.

As shown in FIG. 26B, when the locator member 414 is fully insertedwithin the sheath 412, the distal portion 460 extends beyond the distalend 420 of the sheath 412. In an alternative embodiment, the locatormember 414 may be attached to an exterior surface (not shown) of thesheath 412, for example, along a track, e.g., cooperating slots,grooves, and the like (not shown) in the sheath 412 and locator member414. The distal tip 462 preferably is substantially soft and/or flexiblesuch that the distal portion 460 substantially atraumatically enters thevessel 490. In this fully inserted position, cooperating detents (notshown) may be engaged to substantially secure the locator member 414axially with respect to the sheath 412. The housing actuator assembly(not shown) may be attached to the sheath 412, e.g., by attaching acontrol wire (not shown) from the housing 424 to the actuator assembly,as described above.

Alternatively, the sheath 412 may include a side port (not shown) at ornear its distal end 420 and a bleed back lumen (also not shown) thatextends from the side port to the proximal end of the sheath 412. Beforeor after insertion of the locator member 414, the sheath 412 may bemanipulated until “bleed back” (i.e., blood entering the side port andpassing proximally through the lumen due to exposure of the side port toblood pressure within the vessel) indicates a desired position for thedistal end 420 of the sheath 412. For example, the sheath 412 may bepartially withdrawn from the vessel 490 before the locator member 414 isinserted into the sheath 412 to minimize contact between the vessel wall498 and the distal portion 460 of the locator member 414 duringinsertion of the locator member 414 into the sheath 412.

As shown in FIG. 26C, the splines 464 may then be directed to theirexpanded configuration, for example, by activating a switch on theproximal end (not shown) of the locator member 414. The sheath 412 andlocator member 414 may then be moved in conjunction with one another,and preferably are together partially withdrawn from the vessel 490,until the splines 464 contact the wall 498 of the vessel 490, as shownin FIG. 26D. Thus, the splines 464 may provide a tactile indication ofthe position of the sheath 412 with respect to the wall 498 of thevessel 490. In addition, the splines 464 may assist in “presenting” thewall 498 of the vessel 490, e.g., for receiving a closure element, suchas clip 426.

Turning to FIG. 26E, with the sheath 412 properly positioned, thehousing 424 may then be actuated, for example, to advance the housing424 distally into the passage 492 to deliver the clip 426. Preferably,movement of the housing 424 with respect to the distal end 420 of thesheath 412 is limited, e.g., by the housing actuator assembly (notshown), as described above. Preferably, the housing 424 may only beadvanced a fixed distance such that the clip 426 substantially engagesthe wall 498 of the blood vessel, e.g., until the barbs 428 penetratebut do not pass completely through the wall 498. Thus, with the splines464 fixed with respect to the distal end 420 of the sheath 412 and thedistal position of the housing 424 fixed, the clip 426 may be advanced apredetermined distance into the passage 492 that is ascertainable andpredictable. This predetermined distance may facilitate properdeployment of the clip 426 with respect to the wall 498 of the vessel490, e.g., to prevent advancement of the clip 426 too far, i.e., intothe vessel 490.

Alternatively, or in addition, the splines 464 include radiopaquemarkers, such that fluoroscopy and the like may be used to monitor andposition the distal portion 460 of the locator member 414. The housing424 and/or closure element 426 may also include radiopaque markers suchthat a relative position of the closure element 426 with respect to thesplines 464, and consequently to the wall 498 of the vessel 490, may beascertained before the closure element 426 is deployed from the housing424.

In a preferred method, the splines 464 automatically return to theircollapsed configuration when the closure element 426 is deployed fromthe housing 424 or when the housing 424 reaches its distal position, asshown in FIG. 26F. For example, the housing actuator assembly (notshown) may contact the locator actuator (also not shown) when thehousing actuator assembly is used to advance the housing 424 to itsdistal position, thereby releasing the locator actuator. Thisenhancement may avoid any risk of contact between the clip 426 and thesplines 464, e.g., which otherwise may risk driving the barbs 428 of theclip 426 through the wall 498 of the vessel 490 and into the splines464. Alternatively, or in addition, the distal portion 460 of thelocator member 414 may be automatically retracted, e.g., into the sheath412, when the closure element 426 is deployed or the housing 424 isadvanced.

Once the clip 426 is successfully deployed within the passage 492, i.e.,into the wall 498 of the vessel 490, the apparatus 410 may be withdrawnfrom the passage 492. If the splines 464 of the locator member 414 arenot automatically collapsed during advancement of the housing 424, thesplines 464 may first be affirmatively collapsed, e.g., by depressingthe locator actuator (not shown). The entire apparatus 410 may then beremoved in one step, or alternatively, the locator member 414 may firstbe withdrawn from the sheath 412 before withdrawing the sheath 412,thereby leaving the clip 426 in place to close and/or seal the passage492.

Turning to FIGS. 29A and 29B, another embodiment of a distal portion 560of a locator member 514 is shown that may be used to position a sheath(not shown) before delivering a closure element (also not shown),similar to the embodiment described above. The locator member 514includes a flexible or semi-rigid tubular body 532 having a proximal end(not shown) and a distal end 536. An actuator wire or rod 538 isslidably disposed with respect to the body 532, e.g., within a lumen 533of body 532. The locator member 514 may include a detent (not shown) onor near its proximal end for securing the locator member 514 to a sheath(not shown).

The locator member 514 includes a distal portion 560 that terminates ina substantially rounded, soft, and/or flexible distal tip 562, possiblyincluding a pigtail (not shown) that may facilitate atraumaticadvancement of the distal portion 560 into a blood vessel or other bodylumen. The locator member 514 preferably has a length relative to thesheath such that the distal portion 560 extends beyond a distal end ofthe sheath when the locator member 514 is fully received in the sheath,similar to the embodiment described above.

A plurality of splines 564 are provided on the distal portion 560 thatmay be selectively expandable between a substantially collapsedconfiguration (shown in FIG. 29A) and a substantially transverseexpanded configuration (shown in FIG. 29B). Preferably, the splines 564are substantially rigid or semi-rigid elements that include hingedregions 566 a, 566 b and 568 that facilitate expansion substantiallytransversely with respect to a longitudinal axis 513 of the locatormember 514. In one embodiment, each spline 564 is a single piece thatincludes a plurality of living hinges 566 a, 566 b and 568.Alternatively, each spline 564 may include multiple segments that areconnected by pins or other hinges (not shown). In a preferredembodiment, the distal portion 560 includes four equally spaced splines564, although the locator member 514 may include more or fewer spineswithout deviating from the scope of the present invention. Optionally,the splines 564 may include radiopaque markers (not shown), similar tothe embodiment described above.

Each spline 564 preferably has a first fixed end 564 a and a secondmovable end 564 b. The second end 564 b may be axially movable towardsthe first end 564 a to cause an intermediate region 564 c of the spline564 to expand transversely outward, thereby defining the substantiallytransverse expanded configuration. In a preferred embodiment, theactuator rod 538 extends through the distal portion 560 and is coupledto the second end 564 b of the splines 564 and/or to distal tip 562 ofthe locator member 514. The rod 538 may be moved axially with respect tothe body 532 to selectively expand the splines 564 between the collapsedand expanded configurations.

Turning to FIG. 30A, a locator actuator 570 may be coupled to thecontrol rod 538 and a proximal end 532 of the locator member 514. Thelocator actuator 570 is configured for directing the control rod 538axially to selectively expand the splines 564, similar to the embodimentdescribed above.

In addition, the locator actuator 570 may allow the splines 564 to beexpanded to one of a plurality of expanded configurations. For example,the locator actuator 570 may include an internal member (not shown),coupled to the control rod 538, that is slidable within an actuator body576. A button 572 extending from the internal member is slidable in anaxial slot 574 in the actuator body 576 for controlling movement of thecontrol rod 538. The button 572 may be moved, thereby moving the controlrod 538 and consequently moving the splines 564. For example, as shownin FIG. 30A, the button 572 may be moved to a position (for example,indicated as “4”) thereby expanding the splines 564 to an expandeddiameter 565 a. If desired, the button 572 may be moved to otheravailable positions to reduce the expanded diameter, for example to thediameter 565 b shown in FIG. 30B. This control of the expanded diameterof the splines 564 may be useful to allow the splines 564 to be deployedwithin body lumens of different sizes. Thus, the splines 564 may beexpanded to a desired size corresponding to the size of the vessel intowhich the locator 514 is introduced, thereby minimizing the risk ofdamage to the vessel due to over expansion of the splines 564.

In an alternative embodiment, shown in FIG. 30B, the locator actuator570′ may include a rotatable dial that controls expansion of the splines564, similar to the linear actuator 570 shown in FIG. 30A. In addition,the locator actuator 570, 570′ may include demarcations indicating asize (not shown), e.g., a diameter of the expanded splines and/or thesize of the body lumen corresponding to the size of the lumen into whichthe locator 514 is to be introduced.

In a further alternative, shown in FIG. 31, a locator member 614 may beprovided that includes splines 664 a, 664 b that may be selectivelyexpanded to different angles. A locator actuator (not shown) may allowcontrolled expansion of the splines 664 a, 664 b to desired angles withrespect to the longitudinal axis 613 of the locator member. For example,a cable or other control wire (not shown) may be extend from the locatoractuator to each of the splines 664 a, 664 b, e.g., through a lumen (notshown) in the locator body 632. Each cable may be directed axially toselectively expand or collapse the spline 664 a, 664 b connected to therespective cable.

For example, a spline 664 b on the posterior side of the locator member614 (away from the surface of the patient's skin) may be expandedtowards the proximal end of the locator member 614 at an acute anglealpha, i.e., corresponding substantially to the angle of the passagethrough the patient's skin to the vessel 690, e.g., about thirty orforty five degrees. In contrast, the spline 664 a on the anterior sideof the locator member 614 (i.e. towards the surface of the patient'sskin) may be expanded away from the proximal end of the locator member614 at an oblique angle of one hundred eighty degrees less “alpha.”Thus, the splines 664 a, 664 b may be expanded to predetermined anglesthat facilitate better contact with the wall of the vessel, e.g., tobetter “present” the vessel wall during deployment of a closure element.

In yet another alternative embodiment, shown in FIG. 32, a locatormember 714, such as those described above, may include a tubular sleeve715 within which a body 732, including splines 764, may be axiallydirected. For example, a proximal end (not shown) of the sleeve 715 maybe fixed to a proximal end (also not shown) of the body 732, e.g., to alocator actuator (not shown), such as those described above. At least adistal portion 717 of the sleeve 715 is formed from a substantiallyrigid, smooth walled tube, such as a hypotube, while the remainder ofthe sleeve 715 may be a portion of the same tube or may be formed from asubstantially flexible or semi-rigid tubular member (not shown).

When the locator member 714 is fully inserted into an introducer sheath712, such as those described above, the distal portion 717 of the sleeve715 extends beyond a distal end 720 of the sheath 712. The splines 764may then be selectively deployed from within the sleeve 715, expanded toa substantially transverse expanded configuration, collapsed, andretracted back into the sleeve 715.

For example, the sheath 712 maybe positioned through a puncture 792 intoa vessel 790, e.g., to perform a procedure within a patient'svasculature, as described above. The locator member 714 may then beinserted into the sheath 712 until the distal portion 717 extends beyondthe distal end 720 of the sheath 712. The splines 764 may then beexpanded, and the sheath 712 and locator member 714 manipulated to adesired position, e.g., such that the splines 764 contact the wall 798of the vessel 790, thereby providing a tactile indication of theposition of the sheath 712.

A closure element, such as clip 726 may then be deployed, e.g., from ahousing (not shown) slidably mounted on the sheath 712. Barbs or tines728 on the clip 726 penetrate into the wall 798 of the vessel 790, e.g.,to close the opening in the wall 798 of the vessel 790, as describedabove. If the barbs 728 penetrate completely through the wall 798 of thevessel 790, the sleeve 715 protects the splines 764 and/or the body 733of the locator member 714. The barbs 728 may engage but not penetrate orotherwise catch on the distal portion 717 of the sleeve 715, because ofits substantially rigid and/or smooth construction. Thus, the barbs 728may not penetrate or otherwise catch on the splines 764 when the clip726 is deployed. The splines 764 may be collapsed and retracted into thesleeve 715, either manually or automatically, similar to the embodimentsdescribed above. When the sheath 712 is withdrawn from the puncture 792,the barbs 728 may slide along the distal portion 717 of the sleeve 715until the distal portion 717 is withdrawn from within the clip 726,whereupon the barbs 728 may move inwards to close and/or seal theopening in the wall 798 of the vessel 790.

In alternative embodiments, the apparatus and methods of the presentinvention may be used to locate an introducer sheath within a bloodvessel and/or to deliver closure elements other than a clip. Forexample, the apparatus may be used to deliver a collagen plug and thelike into the passage, or a sealing material (either alone, or inconjunction with a clip).

VI. Fifth Closure System Embodiment

Turning to FIGS. 33-36, which show a first preferred embodiment of anapparatus 810 for delivering a closure element, such as a clip 805(shown in phantom), into an opening through tissue for closing theopening (not shown). Generally, the apparatus 810 includes an introducersheath 812, a housing or carrier assembly 814 slidably disposed on thesheath 812, and an actuator or actuator assembly 816 that is connectableto the introducer sheath 812. In addition, the apparatus 810 may alsoinclude a locator member or obturator 818, which may be part of theactuator assembly 816, as shown in FIGS. 33-35.

As best seen in FIGS. 33 and 36, the introducer sheath 812 is generallya substantially flexible or semi-rigid tubular member including a lumen820 extending along a longitudinal axis 828 between its proximal anddistal ends 822, 824. The distal end 824 has a size and shape tofacilitate insertion into an opening through tissue (not shown), e.g.,having a tapered tip 826 for facilitating substantially atraumaticintroduction through a passage and/or at least partially into a bloodvessel or other body lumen accessed via the passage. The lumen 820 has asize for accommodating insertion of one or more devices therethrough,such as a catheter, guidewire, and the like (not shown).

Returning to FIGS. 33, 36, and 37, a hub assembly 830 is attached to theproximal end 822 of the sheath 812, e.g., by an adhesive, cooperatingconnectors, and/or a thermo-mechanical joint. Thus, the hub assembly 830and the sheath 812 may define a passage 838 (see FIG. 33) therebetweenthat extends substantially parallel to the longitudinal axis 828. Thehub assembly 830 may include a keel member 1020 and one or more outerannular bodies 1022-1026 that may be attached to one another, e.g.,using butt or lap joints secured with adhesives, mechanical connectors,and the like.

For example, the hub assembly 830 may include a rear main body 1022, aspacer 1023, a nose ring 1024, and a strain relief forward nose 1026that may be substantially permanently attached to one another. The keelmember 1020 may include a tubular portion 1046, and a shoulder portion1048 connected by a radial spoke 1050 that may extend transversely withrespect to the longitudinal axis 828. The proximal end 822 of the sheath812 may be connected to the tubular portion 1046 such that a passage1052 through the tubular portion 1046 communicates with the lumen 820.The main body 1022 and nose ring 1024 may be connected to the shoulderportion 1048 such that an annular passage 838 may be defined between thetubular portion 1046 and the main body 1022 and nose ring 1024. Thepassage 838 may have a “C” shape along the portion of the hub assembly830 through which the spoke 1048 of the keel member 1020 extends.

With particular reference to FIG. 36, the hub assembly 830 may alsoinclude one or more seals and/or valves that provide a fluid-tight seal.Thus, one or more devices, such as the obturator 818 (not shown in FIG.36), may be inserted into the lumen 820 of the sheath 812 without fluidpassing proximally through the lumen 820. For example, the hub assembly830 may include a thrust washer and/or valve 1028, a valve 1030, a guide1032 for directing devices into the lumen 820 of the sheath 812, and aseal 1034. The various seals and/or guides may be secured to the hubassembly 830 by a spacer 1036 and/or an end cap 1038.

In addition, the hub assembly 830 may include one or more connectors onits proximal end 832, such as tabs 834 (see FIG. 33) and/or recesses orpockets (not shown) for cooperating with mating connectors on theactuator assembly 816, as described further below. Optionally, the hubassembly 830 may also include a side port 836 that extends from theshoulder portion 1048 to the passage 1052, thereby communicating withthe lumen 820. The side port 836 may communicate with tubing 837 (seeFIG. 35A), for example, to infuse fluids into the lumen 820 through thesheath 812. Alternatively, or in addition, the side port 836 may providea “bleed back” indicator, such as that disclosed in application U.S.Pat. No. 6,626,918, which is incorporated herein by reference.

Returning to FIG. 36, the carrier assembly 814 is slidably disposed onan exterior of the sheath 812 and is configured for releasably holdingthe clip 805. The carrier assembly 814 is preferably slidable from aproximal position, e.g., near, adjacent to, or at least partiallydisposed within the passage 838, to one or more distal positions towardsthe distal end 824 of the sheath 812, as explained further below.Optionally, the hub assembly 830 may include a carrier release pin 1040that may be inserted into a hole, slot, or other aperture 1042 in theshoulder portion 1048. An inner tip 1044 of the pin 1040 may be receivedin one or more corresponding holes 851, 861, 871 (best seen in FIG. 38A)in the carrier assembly 814. The pin 1040 may provide a safety feature,e.g., preventing premature advancement of the carrier assembly 814and/or deployment of the clip 805, and/or may assist in aligning thecarrier assembly 814 as will be appreciated by those skilled in the art.

As best seen in FIGS. 38A and 38B, the carrier assembly 814 may includean inner carrier member 840, a middle pusher member 842, and an outeranchor member 844 that may be nested together and coaxially disposedaround the sheath 812 (shown in phantom in FIG. 38B). The carrier member840 is an annular-shaped body 832 including proximal and distal ends846, 848. As used herein, an “annular-shaped body” or “annular body”(whether referring to the carrier assembly 814 or the clip 805) includesany hollow body, e.g., including one or more structures surrounding anopening, whether the body is substantially flat or has a significantthickness or depth. Thus, although an annular-shaped body may becircular, it may include other noncircular shapes as well, such aselliptical or other shapes that are asymmetrical about a central axis.

A tongue 850 may extend proximally from the proximal end 846substantially parallel to the longitudinal axis 828. The tongue 850 mayinclude a tab 852 or other connector, having a ramped proximal edge 852a and a substantially blunt distal edge 852 b, for coupling movement ofthe carrier member 840 to the actuator assembly 816, as describedfurther below. The distal end 848 of the carrier member 840 may betapered or otherwise configured for facilitating substantiallyatraumatic advancement of the carrier member 840 through tissue, also asdescribed further below.

The pusher member 842 is also an annular body 854, including proximaland distal ends 856, 858 and a tongue 860 extending from the proximalend 856 having a tab 862 thereon. The pusher member 842 is configured toslidably fit around the carrier member 840, but has a substantiallyshorter length than the carrier member 840. Thus, the carrier and pushermembers 840, 842 may at least partially define a space 815 distal to thedistal end 858 of the pusher member 842 and along an outer surface ofthe carrier member 840.

The anchor member or ring 844 may also be an annular body 864, includingproximal and distal ends 866, 868 and a tongue 870 extending from theproximal end 866 having a tab 872 thereon, similar to the carrier andpusher members 840, 842. The anchor member 844 preferably includes anouter skin or sleeve 845 (shown in phantom in FIG. 38B) attached to andextending distally from the distal end 868 of the anchor ring 844,thereby extending over the space 815 to define a space (not shown). Forexample, the outer sleeve 845 may be lapped over and/or bonded to theanchor member 844.

The outer sleeve 845 may be formed from a substantially flexiblematerial, which may be inelastic or elastic, and/or may include asubstantially slippery outer surface. Exemplary materials includepolytetrafluoroethylene (PTFE), polyethylene terephthalate (PET) orother polyester, latex, silicone, polyamides, polyurethanes, and/orblends or copolymers thereof. The outer sleeve 845 may have a lengththat is substantially longer than the carrier member 840 such that theouter sleeve 845 extends beyond the distal end 848 of the carrier member840. For example, the outer sleeve 845 may extend up to fifteenmillimeters (15 mm) or more beyond the carrier member 840 and/or mayslidably surround the sheath 812. The outer sleeve 845 may protect theclip 805 or tissue through which the carrier assembly 814 is advanced,and/or may facilitate advancing the carrier assembly 814 throughmultiple layers of tissue, as explained further below.

Optionally, the outer sleeve 845 may include weakened regions, e.g.,longitudinal slots or perforations 845 a or thin walled regions (notshown), that may be torn, expanded, and/or enlarged during advancementof the carrier and pusher members 840, 842 relative to the outer sleeve834, as explained further below. For example, the outer sleeve 845 mayinclude a plurality of longitudinal slots 845 a with circumferentiallyadjacent slots being staggered longitudinally from one another, as shownin FIG. 38C. This slot arrangement may facilitate the outer sleeve 845expanding or being deflected out of the way upon advancing the carrierand pusher members 840, 842 without fully exposing the clip 805, asexplained further below. Alternatively, as shown in FIG. 38D, thelongitudinal slots may be spiral slots 845 a′ formed in the outer sleeve845,′ Spiral slots 845 a′ may minimize tissue moving as the carrierassembly 814 is advanced through tissue (not shown), as describedfurther below.

In a further alternative, a substantially flexible sleeve or skin (notshown) may be provided that extends over the space 815, similar to theouter sleeve 845, but that may be bonded or otherwise secured to theouter surface of the introducer sheath 812. Embodiments of such a skinmay be found in U.S. Pat. No. 6,749,621, which is incorporated herein byreference. In yet another alternative, it may be possible to eliminatethe anchor member 844 and/or the outer sleeve 845 completely, such thatthe clip 805 remains exposed on the carrier member 840.

In a preferred embodiment, the carrier, pusher, and anchor members 840,842, 844 are coaxially disposed with respect to one another such thatthey telescope at least partially within one another. When the carrier,pusher, and anchor members 840, 842, 844 are coaxially disposed, thetongues 850, 860, 870 preferably overlap and/or are coextensive with oneanother, as shown in FIG. 38B). The tabs (only tab 872 is shown in FIG.38B) may also be aligned with one another. Each of the tongues 850, 860,870 is preferably tapered to facilitate attachment of the actuatorassembly 816, as described further below. The tongues 850, 860, 870 mayinclude holes 851, 861, 871 that may be aligned with one another whenthe carrier, pusher, and anchor members 840, 850, 860 are aligned withinone another. The holes 851, 861, 871 may be sized for receiving a pin1040 (not shown, see FIGS. 35A and 36), or an alignment detent (notshown) for ensuring that the carrier, pusher, and anchor members 840,850, 860 are properly aligned over one another before using theapparatus 810.

The carrier assembly 814 may be used to deploy a clip 805 or otherclosure element from the space 815 defined by the carrier assembly 814.In a preferred embodiment, the clip 805 is a generally annular-shapedclip, including one or more barbs and/or tines 807 for engaging thetissue around an opening, e.g., in or adjacent to a wall of a bloodvessel (not shown). Preferably, the clip 805 is configured for drawingthe tissue around a puncture in the wall of the vessel substantiallyclosed and/or for enhancing hemostasis within the puncture. Exemplaryembodiments of a closure element are disclosed in U.S. Pat. Nos.6,197,042, 6,461,364, 6,391,048, 6,623,510, which are incorporatedherein by reference.

Returning to FIGS. 33 and 35A, the carrier assembly 814 is actuable fromthe proximal end 822 of the sheath 812, preferably by the actuatorassembly 816. The carrier assembly 814 may be substantially permanently,but slidably, disposed on the sheath 812. For example, the carrierassembly 814 may be initially stored at least partially within thepassage 838 under the hub 830, e.g., under the strain relief nose 1026.Alternatively, the carrier assembly 814 may be provided separate as aseparate assembly (not shown), e.g., with the clip 805 pre-loadedtherein, that may be slidably received on the sheath 812.

Turning to FIGS. 33-35B, 39A, and 39B, the actuator assembly 816generally includes a handle body or housing 874 and a plurality oftelescoping actuator members 876, 878, 880. Preferably, the housing 874includes mating handle covers 874 a, 874 b, and a nose cover 875 withinwhich the actuator members 876, 878, 880 are slidably mounted. Thehandle body 874 may include one or more cooperating connectors forconnecting the actuator assembly 816 to the sheath 812. For example, thenose cover 875 may include pockets 884 (see FIG. 33) for receiving tabs834 on the hub assembly 830. Thus, the actuator assembly 16 may besubstantially permanently attached to the sheath 812, as describedfurther below. In addition, the actuator assembly 816 may include aframe subassembly 990, and side-plates 991, which may secure theobturator assembly 818 relative to the housing 874, as explained furtherbelow.

In the preferred embodiment shown in FIGS. 39A and 39B, the telescopingactuator members 876, 878, 880 include an inner tubular member 876, anintermediate tubular member 878, and an outer tubular member 880.Preferably, the actuator members 876-880 are substantially rigid membershaving longitudinal slots 886, 888, 890 therein, thereby defininggenerally “C” shaped cross-sections over at least a substantial portionof their lengths. Each of the longitudinal slots 886, 878, 890 may havea width similar to a width of the tongues 850, 860, 870 on the carrierassembly 814, as described further below. The longitudinal slots 886,878, 890 extend predetermined distances from distal ends 892, 894, 896of the respective tubular members 876, 878, 880 towards, but notnecessarily completely to, their proximal ends (not shown).

The distal ends 892, 894, 896 include detents for engaging respectivedetents on the carrier assembly 814. For example, the detents may bepockets 904, 906, 908 including a tapered proximal edge and asubstantially blunt distal edge (only edges 908 a, 908 b are shown andlabeled in FIG. 39B), similar to the respective tabs 852, 862, 872 onthe carrier, pusher, and anchor members 840, 842, 844 (see FIG. 38A).Thus, movement of the carrier, pusher, and anchor members 840, 842, 844may be coupled to the inner, intermediate, and outer actuator members876, 878, 880, respectively, when the tongues 850, 860, 870 are receivedin the slots 886, 888, 890.

Returning to FIGS. 33-35A, the actuator assembly 816 also includes acontrol member, such as knob 910 and shaft 912, that are coupled to theinner, intermediate, and/or outer actuator members 876, 878, 880.Preferably, the shaft 912 is connected only to the intermediate actuatormember 878. Thus, axial movement of one or more of the actuator members876, 878, 880 may be attained by applying an axial force to the knob910.

The inner, intermediate, and outer actuator members 876-880 include oneor more sets of cooperating detents for coupling distal movement of theinner, intermediate, and outer actuator members 876-880 in apredetermined manner, as the knob 910 is directed distally. The term“detents” refers to any combination of mating elements, such as tabs,pockets, slots, ramps, cantilevered members, and the like, that may beselectively or automatically engaged and/or disengaged to couple ordecouple the actuator members 876-880 relative to one another. Thecooperating detents described below are merely exemplary and notexhaustive.

Preferably, the cooperating detents include a first set of cooperatingdetents for releasably coupling the outer tubular member 880 to theinner and intermediate tubular members 876, 878. When the carrierassembly 814 reaches a first distal position, e.g., near the distal end824 of the sheath 812, the outer tubular member 880 may be decoupled andpreferably anchored from further substantial axial movement. As the knob910 is directed further distally, the inner and intermediate tubularmembers 876, 878, and consequently the carrier and pusher members 840,842, may continue to be directed distally, while the outer tubularmember 880 and the sheath member 844 remain anchored in place.

FIGS. 40A and 40B show a preferred embodiment of a first set ofcooperating detents for releasably coupling the outer tubular member 880to the inner and intermediate tubular members 876, 878. The outertubular member 880 includes a first detent or tab 914 (or optionallymultiple detents, not shown) and the inner and intermediate tubularmembers 876, 878 include first pockets 916, 918 for receiving the firsttab 914 therein. Thus, with the first tab 914 received in the firstpockets 916, 918, any axial force (in either direction) moving one ofthe tubular members 876-880 moves all of them.

First and second ramps 920, 922 are provided on the outer tubular member880 and the housing 874 of the actuator assembly 816 (only a portion ofwhich is shown) of the sheath 812 (not shown). The first and secondramps 920, 922 slidably engage one another as the actuator members 876,878, 880 and/or the carrier assembly 814 (not shown) reach the firstdistal position. Alternatively, the second ramp 922 may be provided on aportion of the hub assembly 830 (not shown). Preferably, the first ramp920 on the outer tubular member 880 defines a free end of a firstcantilevered beam 924 from which the first tab 914 extends inwardly. Thebeam 924 includes a hole 926 therethrough and the second ramp 922, whichis relatively stationary, includes a recess or other feature 928therein.

The actuator members 876, 878, 880 may be advanced distally (indirection of arrow) until the cooperating first and second ramps 920,922 slidably engage one another. As the actuator members 876, 878, 880are advanced further distally, the first ramp 920 slides up onto thesecond ramp 922, thereby deflecting the first beam 924 outwardly untilthe first tab 914 is disengaged from the first pockets 916, 918, asshown in FIG. 40B. Further, upon attaining the first distal position, asurface 929 in the hole 926 on the flange 924 and the feature 928 in thesecond ramp 922 preferably interlock or otherwise contact one another.This contact may secure the outer tubular member 880 from subsequentaxial movement, while still allowing the inner and intermediate tubularmembers 876, 878 to be directed distally beyond the first distalposition. In an alternative embodiment, it may be possible to eliminatethe ramp 920 on the first beam 924, while still allowing the free end ofthe first beam 924 to be deflected radially outward by the second ramp922.

In addition to the first set of cooperating detents described above, theactuator assembly 816 may include a second set of cooperating detentsfor releasably coupling the inner tubular member 876 and theintermediate tubular member 878 and/or recoupling the inner and outertubular members 876, 880. Thus, the inner and intermediate tubularmembers 876, 878 may be directable to a second distal position distal tothe first distal position (while the outer tubular member 880 remainssubstantially stationary). When the carrier and pusher members 840, 842approach the second distal position, the cooperating detents maydecouple the intermediate tubular member 878 from the inner tubularmember 876 and/or anchor the inner tubular member 876 in place, e.g.,relative to the outer tubular member 880. The intermediate tubularmember 878, and consequently the pusher member 842 (not shown), may thenbe advanced further distally beyond the second distal position, asdescribed further below.

Turning to FIGS. 41A-41D, an exemplary second set of cooperating detentsis shown that includes a second tab or other detent 930 on theintermediate tubular member 878 and a second pocket 932 in the innertubular member 876. The second tab 930 may be received in the secondpocket 932 for coupling movement of the inner and intermediate tubularmembers 876, 878 together.

The outer tubular member 880 includes a spring element 938 that isconfigured for disengaging the second tab 930 from the second pocket 932upon attaining the second distal position. For example, the springelement 938 may include a transverse beam 940 that extends from a thirdcantilevered beam 941 on the outer tubular member 880. The transversebeam 940 extends through slots 942, 944 in the inner and intermediatetubular members 876, 878, e.g., transversely to the longitudinal axis828, and preferably substantially perpendicular to the longitudinal axis828.

Preferably, the transverse beam 940 has an inverted “T” shape, as bestseen in FIGS. 41C and 41D, defining one or more shoulders 946 adjacent astem 948. The slots 942, 944 may have narrow regions 942 a, 944 a andwide regions 942 b, 944 b proximal to the narrow regions 942 a, 944 a.Preferably, the narrow regions 942 a, 944 a have a width less than theshoulders 946, but wider than the stem 948. In contrast, the wideregions 942 b, 944 b have a width greater than a width of the shoulders946. In addition, the narrow regions 942 a, 944 a and wide regions 942b, 944 b are disposed along the longitudinal axis 828 at predeterminedlocations such that the transverse beam 940 coincides with the wideregions 942 b, 944 b approximately at the second distal position.

Consequently, before the inner and intermediate tubular members 876, 878reach the second distal position, the shoulders 946 may slide along theouter surface of the intermediate tubular member 878 while the stem 948slides inside the narrow region 942 a, 944 a of the slots 942, 944.Alternatively, the shoulders 946 may slide along an outer surface (notshown) of the inner member 876 if the slot 944 is wide its entirelength. The tip 950 of the transverse beam 940 may move along the innertubular member 876, e.g., at a predetermined clearance from the innersurface thereof such that the tip 950 does not touch the inner surfaceof the inner tubular member 876. Alternatively, the tip 950 may slidealong the inner surface of the inner tubular member 876.

When the inner and intermediate tubular members 876, 878 approach orattain the second distal position, the shoulders 946 may enter the wideregions 942 b, 944 b, e.g., due to the bias of the beam 941. This actionmay produce two substantially simultaneous results. First, when theshoulders 946 enter the wide regions 942 b, 944 b, i.e., such that thebeam 940 moves transversely, the tip 950 of the beam 940 may push thesecond tab 930 radially outward, thereby disengaging the second tab 930from the second pocket 932. Thus, further distal movement of theintermediate tubular member 878 may be allowed independent of the innertubular member 876. In addition, the shoulders 946 of the beam 940 mayenter the wide region 942 b of the slot 942. Because the wide region 942b has a size corresponding substantially to a cross-section of thetransverse beam 940, the inner tubular member 876 is consequentlycoupled to the outer tubular member 880 as it is disengaged from theintermediate tubular member 878.

Thus, the inner tubular member 876 may be substantially locked in place,e.g., to the outer tubular member 880 since the outer tubular member 880has been previously secured in place. Preferably, these two actions,i.e., releasing the intermediate tubular member 880 and securing theinner tubular member 876 in place occur substantially simultaneously.

Returning to FIGS. 33-35B, the actuator assembly 816 also includes theobturator assembly 818 mounted within the housing 874. Generally, theobturator assembly 818 includes a flexible or semi-rigid tubular body orother elongate rail 972 having a proximal end 974, a distal end 976, anda distal portion 984. An actuator rod, wire, or other elongate member978 is slidably disposed with respect to the rail 972, e.g., within alumen of the rail 972.

In addition, the obturator assembly 818 includes an obturator housing980 on the proximal end 974 of the rail 972. The obturator housing 980may include one or more tabs 992 for engaging complementary slots 994 inthe side plates 991. Thus, the obturator assembly 818 may be securedwithin the housing 874 of the actuator assembly 816 when the tabs 992are received in the slots 994. The side plates 991 may be connected tothe frame subassembly 990, and the handle covers 874 a, 874 b aresecured over the side plates 991. When the obturator assembly 818 ismounted within the housing 874, the rail 972 may extend through theactuator members 876, 878, 880, e.g., until the distal portion 982extends beyond the distal ends 892, 894, 896 of the actuator members876, 878, 880.

Turning to FIGS. 42A and 42B, the distal portion 982 of the obturatorassembly 818 includes a substantially rounded, soft, and/or flexibledistal tip 984. Optionally, the distal tip 984 may include a pigtail(not shown) that may facilitate atraumatic advancement of the distalportion 982 into a blood vessel or other body lumen (not shown). Theobturator assembly 818 preferably has a length relative to the sheath812 such that the distal portion 982 extends beyond the distal end 824of the sheath 812 when the obturator assembly 818 is in a deployedposition (shown in FIGS. 44C and 44D), as explained below.

One or more, and preferably a plurality of, positioning elements 986 areprovided on the distal portion 982 that may be selectively expandablebetween a substantially axial collapsed configuration (shown in FIG.42A) and a substantially transverse expanded configuration (shown inFIG. 42B). Preferably, the positioning elements 186 are substantiallyflexible splines configured for expanding substantially transverselywith respect to the longitudinal axis 828.

In one embodiment, the obturator assembly 818 includes four splines 986that are substantially equally spaced about the distal portion 982.Alternatively, the obturator assembly 818 may include a pair of splines(not shown) that are disposed generally opposite one another about thedistal portion. The obturator assembly 818 may include more or fewersplines without deviating from the scope of the present invention.Additional embodiments of positioning elements are disclosed inco-pending application U.S. Pat. No. 6,780,197, the disclosure of whichis expressly incorporated herein by reference.

Optionally, the splines 986 may include radiopaque markers (not shown)or may be wholly or partially formed from radiopaque material tofacilitate observation of the splines 986 using fluoroscopy or otherimaging systems. Alternatively, or in addition, the carrier assembly 814may include one or more radiopaque markers, e.g., at its distal end (notshown) and/or the clip 805 may include radiopaque marker(s) or may bemade from radiopaque material. This may facilitate monitoring thelocation of the clip 805 relative to the splines 986, as describedfurther below.

Returning to FIGS. 42A and 42B, each spline 986 preferably has a firstfixed (e.g., proximal) end 986 a and a second movable (e.g., distal) end986 b. The second end 986 b may be axially movable towards the first end986 a to cause an intermediate region 986 c of the spline 986 to buckleand/or expand transversely outwardly, thereby defining the substantiallytransverse expanded configuration. In a preferred embodiment, anactuator rod 978 extends through the distal portion 982 and is coupledto the distal tip 984 of the obturator assembly 818 and/or to one of thefirst and second ends 986 a, 986 b. The actuator rod 978 may be movedaxially, e.g., proximally, with respect to the rail 972 to selectivelyexpand the splines 186 between their collapsed configuration and theirexpanded configuration.

Turning to FIGS. 44B-44D, the obturator housing 980 (not shown, see FIG.35A) is configured for selectively deploying the distal portion 982and/or moving the splines 986 between their collapsed and expandedconfigurations. For example, the obturator housing 980 may include aswitch 988 that may be depressed or rotated. Initially, as shown in FIG.44B, the distal portion 982 may be retracted within the distal end 824of the sheath 812. As the switch 988 is activated, e.g., depressed, thedistal portion 982 may be deployed from the distal end 824 of the sheath812, as shown in FIG. 44C. As the switch is further depressed, thesplines 986 may be expanded to the expanded configuration, as shown inFIG. 440.

For example, the rail 972 and rod 978 may initially be moved together,e.g., to deploy the distal portion 982, as shown in FIG. 44C. Oncedeployed, the rod 978 may stop moving, the rail 972 may continue toadvance, thereby buckling the splines 986 as the first and second ends986 a, 986 b become closer to one another, as shown in FIG. 44D.Alternatively, after deploying the distal portion 982, the rod 978 maybe retracted proximally to expand the splines 986.

The obturator housing 980 (see FIG. 35A) preferably includes a lock 989for securing the rod 978 and rail 972 relative to one another, e.g., tolock the splines 986 in their expanded configuration. The lock may bereleased, for example, by depressing the switch 988 again, by activatingan emergency release (not shown) and/or by activating a releasemechanism (not shown) when the carrier assembly 814 is advanced, asexplained below. The obturator housing 980 may include a spring or otherbiasing mechanism (not shown) for biasing the rail 972 and/or rod 978 toreturn the splines 986 to their collapsed configuration and/or toretract the distal portion 982 back into the sheath 812 when the lock isreleased. For example, the lock may be released upon advancing theactuator members 876, 878, 880 to a predetermined position, e.g., beforeor after attaining the second distal position, as explained furtherbelow.

Alternatively, as shown in FIGS. 43A and 43B, an apparatus 1110 fordelivering a closure element 805 may be provided that includes aseparate obturator assembly 1118 that may be inserted into or otherwiseconnected to an actuator assembly 1116. For example, the actuatorassembly 1116 may include a lateral port 1152 with an inner passage 1154that communicates with an interior region or lumen (not shown) ofactuator members 1176-1180 of the actuator assembly 1116.

At any time before advancing the carrier assembly 1114 to deploy theclip 805 thereon, the obturator assembly 1118 may be inserted into thelateral port 1152, thereby introducing a distal portion 1182 of theobturator assembly 1118 into the sheath 1112. An obturator housing 1181of the obturator assembly 1118 may include one or more detents (notshown) for engaging complementary-shaped detents (also not shown) on thelateral port 1152. Thus, the obturator assembly 1118 may besubstantially secured axially with respect to the lateral port 1152, andconsequently relative to the actuator assembly 1116 and sheath 1112.Otherwise, the actuator and obturator assemblies 1116, 1118 may operatesimilar to the previous embodiment.

Turning to FIGS. 44A-44H, an apparatus 810 (the entire apparatus 810 isshown in FIGS. 44B-44F), such as that shown in FIG. 33, may be used todeliver a closure device, such as a clip 805, to close and/or seal anincision, puncture, or other opening. For example, the apparatus 810 maybe used to deliver the clip 805 through a passage 892 that extends froma patient's skin 894, through intervening tissue 896, and into a wall898 of a blood vessel 890. Alternatively, the apparatus 810 may be usedto deliver other annular shaped devices (not shown) that may be disposedwithin the carrier assembly 814.

As shown in FIG. 44A, the sheath 812, without the actuator assembly 816(not shown), may be inserted or otherwise positioned within the bloodvessel 890, i.e., through the passage 892. The sheath 812 is preferablyprovided with the carrier assembly 814 in its proximal position, e.g.,adjacent to or within the hub assembly 830. The sheath 812 may beadvanced over a guide wire or other rail (not shown) previouslypositioned through the passage 892 into the blood vessel 890 usingconventional procedures. Preferably, the blood vessel 890 is aperipheral vessel, such as a femoral or carotid artery, although otherbody lumens may be accessed using the sheath 812, as will be appreciatedby those skilled in the art.

The passage 892, and consequently the sheath 812, may be oriented withrespect to the vessel 890, thereby facilitating introduction of devicesthrough the lumen 820 of the sheath 812 into the vessel 890 with minimalrisk of damage to the vessel 890. One or more devices, such as a guidewire, a catheter, and the like (not shown), may be inserted through thesheath 812 and advanced to a desired location within the patient's body.For example, the devices may be used to perform a therapeutic ordiagnostic procedure, such as angioplasty, atherectomy, stentimplantation, and the like, within the patient's vasculature. After theprocedure is complete, the device(s) may be removed from the sheath 812,and the actuator assembly 16 may be attached to the hub assembly 830 ofthe sheath 812.

Turning to FIG. 44B, along with FIGS. 39A, and 39B, the longitudinalslots 886-890 in the actuator members 876, 878, 880 may be aligned withthe side port 836 extending from the hub assembly 830. This may alignthe “C” shaped cross-sections of the tubular members 876-880 with thespoke (not shown) extending across the passage 838. The distal portion982 of the obturator assembly 18 may then be inserted into the lumen 820of the sheath 812, and advanced towards the distal end 24 of the sheath812. The actuator members 876, 878, 880 may also be inserted into thepassage 838, thereby disposing the distal portion 982 in a predeterminedrotational orientation relative to the sheath 812. Once the actuatormembers 876, 878, 880 are fully received in the passage 838, theconnectors 834, 884 (not shown, see FIG. 33) may engage to secure theactuator assembly 816 to the hub assembly 830.

The carrier assembly 814 is also disposed at least partially within thepassage 838 (not shown in FIGS. 39A and 39B) such that the tongues 850,860, 870 on the carrier, pusher, and anchor members 840, 842, 844 arealigned with the side port 836. Consequently, the tongues 850, 860, 870may be aligned with the longitudinal slots 886, 888, 890 in the actuatormembers 876, 878, 880 as the actuator members 876, 878, 880 are insertedinto the passage 838.

Thus, as the actuator members 876, 878, 880 are advanced into thepassage 838, the tongues 850, 860, 870 may be received in thelongitudinal slots 886, 888, 890, preferably until the tabs 852, 862,872 are received in the pockets 904, 906, 908, as best seen in FIG. 39B.The tongues 850, 860, 780 are preferably at least partially tapered,thereby self-aligning with the longitudinal slots 886, 888, 890, e.g.,to correct any slight misalignment. With the tongues 850, 860, 870engaged within the longitudinal slots 886, 888, 890, the carrier,pusher, and sheath members 840, 842, 844 may be coupled to the inner,intermediate, and outer tubular members 876, 878, 880, respectively.Thus, once the actuator assembly 816 is secured to the hub assembly 830,the distal portion 982 of the obturator assembly 16 is preferablydisposed adjacent the distal end 824 of the sheath 812 within the lumen820, as best seen in FIG. 44B.

Alternatively, for the apparatus 1110 shown in FIGS. 43A and 43B, theactuator assembly 1116 may be attached to the hub assembly 330 withoutthe obturator assembly 1118. The obturator assembly 1118 may then beinserted into the lateral port 1152, through the interior of theactuator members 1176-1180, and into the lumen 1120 of the sheath 1112at any time before deploying the clip 805. Thus, the distal portion 1182of the obturator assembly 1118 may be disposed adjacent the distal end1124 of the sheath 1112, similar to the actuator assembly 816.

Turning to FIG. 44C, the distal portion 982 of the obturator 818 may beadvanced beyond the distal end 824 of the sheath 812, for example, bydepressing the switch 988 on the actuator assembly 816. The distal tip984 preferably is substantially soft and/or flexible such that thedistal portion 982 substantially atraumatically enters the vessel 890.In this fully inserted position, cooperating detents (not shown), e.g.,on the actuator housing 980 and the rail 972 of the actuator assembly816, may be engaged to substantially secure the distal end 982 of theobturator 818 beyond the distal end 824 of the sheath 812.

Turning to FIG. 44D, the splines 986 may then be directed to theirexpanded configuration, for example, by further depressing the switch988 on the actuator assembly 816. Preferably, the distal portion 982 isdeployed and the splines are expanded in a single motion, e.g., byactivating the switch 988. Alternatively, these steps may be performedindependently from one another if desired.

Turning to FIG. 44E, the entire apparatus 810, including the sheath 812and splines 986, may then be moved, e.g., by manipulating the actuatorassembly 816. Preferably, the apparatus 810 is partially withdrawn fromthe vessel 890 until the splines 986 contact the wall 898 of the vessel890, as shown. Thus, the splines 986 may provide a tactile indication ofthe position of the distal end 824 of the sheath 812 with respect to thewall 898 of the vessel 890. In addition, the splines 986 may assist in“presenting” the wall 898 of the vessel 890, e.g., for receiving theclip 805 (or other closure element) if the clip 805 is to engage thewall 898.

Turning to FIG. 44F, with the sheath 812 properly positioned, thecarrier assembly 814 may be advanced along the sheath 812, i.e., intothe passage 892 to deliver the clip 805. For example, a distal force maybe applied to the knob 910, thereby advancing the actuator members 876,878, 880 and consequently the carrier assembly 814 distally over thesheath 812. Because the actuator members 876, 878, 880 are all coupledtogether, as described above, the carrier assembly 814 advances with theouter sleeve 845 on the anchor member 844 substantially covering theclip 805. Because of the tapered configuration of the outer sleeve 845and the carrier member 840, the carrier assembly 814 may be advancedthrough the passage 892 substantially atraumatically. In addition,because the clip 805 is substantially covered by the outer sleeve 845,the tissue surrounding the passage 892 may not be exposed to the tines807 on the clip 805, which otherwise may inadvertently catch the tissueand damage the tissue and/or the clip 805. Further, the outer sleeve 845may facilitate advancing the carrier assembly 814 through interveninglayers of tissue, such as one or more layers of fascia (not shown) thatmay be encountered between the skin 894 and the wall 898 of the vessel890.

When the carrier assembly 814 reaches a first distal position (FIG.44F), the first set of cooperating detents (not shown, but describedabove with reference to FIGS. 40A and 40B) are disengaged to release theouter tubular member 880 with respect to the inner and intermediatetubular members 876, 878. The first beam 924 on the outer tubular member880 may slidably engage the second ramp 922 on the housing 874, therebydisengaging the first tab 914 from the first pockets 916, 918. Inaddition, the outer tubular member 880 is preferably substantiallysecured at the first distal position, e.g., when the hole 926 in thefirst beam 924 interlocks a recess 928 in the second ramp 922 (as shownin FIG. 40B).

Turning to FIG. 44G, as the distal force continues to be applied to theknob 910 (not shown), the inner and intermediate tubular members 876,880, and consequently the carrier and pusher members 840, 842, may beadvanced further distally. As the carrier and pusher members 840, 842are advanced relative to the outer sleeve 845, they may cause the outersleeve 845 to expand to accommodate their advancing between the outersleeve 845 and the sheath 812. To facilitate this advancement withouttearing the outer sleeve 845, the outer sleeve 845 may includelongitudinal slots, e.g., either straight slots 845 a, as shown in FIG.38C, or spiral slots 845 a,′ as shown in FIG. 38D. The slots 845 a, 845a′ may open as the carrier and pusher members 840, 842 are advanced,such that the outer sleeve 845 expands to assume a zigzag meshconfiguration. In particular, the spiral slots 845 a′ may translateaxial forces to torsional forces due to the spiral shape of the slots845 a,′ e.g., such that the outer sleeve 845′ twists as it expands,causing the surrounding tissue 896 to rotate about the longitudinal axis828, thereby minimizing the tissue 896 being pushed distally as thecarrier and pusher members 840, 842 are advanced through the tissue 896.

When the carrier and pusher members 840, 842 reach a second distalposition, the second set of cooperating detents (not shown, butdescribed above with reference to FIGS. 41A-41D) interact to release theintermediate tubular member 878 from the inner tubular member 876. Forexample, the transverse beam 940 may push the second tab 930 out of thesecond pocket 932 (as best seen in FIG. 41B). In addition, substantiallysimultaneously with this action, the second set of detents alsopreferably substantially secure the inner tubular member 876, e.g., byinterlocking the transverse beam 940 in the wide portion 942 b of slot942.

As shown in FIG. 44H, the intermediate tubular member 878 may then beadvanced further distally by continuing to apply a distal force to theknob 910 (not shown). Thus, the pusher member 842 may be advanceddistally relative to the carrier member 840, thereby forcing the clip805 distally off the carrier member 840 and preferably into engagementwith the wall 898 of the vessel 890 or other tissue surrounding thepassage 892.

In a preferred method, shown in FIG. 44I, the splines 986 mayautomatically return to their collapsed configuration and/or may beretracted into the sheath 812 during deployment of the clip 805. Forexample, the splines 986 may be collapsed as the clip 805 is partiallydeployed from the carrier assembly 814, e.g., before the clip 805 iscompletely collapsed towards its closed position. The orientation of theclip 805 and the splines 986 about the longitudinal axis 828 may be suchthat tines 807 of the clip 805 are disposed between the splines 986 asthe clip 805 is deployed. Thus, as the tines 807 are driven into thewall of the vessel 890, the tines 807 may avoid being driven into thesplines 986. Embodiments of a clip and delivery apparatus that providesuch an orientation are disclosed in incorporated U.S. Pat. No.6,197,042.

For example, as the intermediate tubular member 878 is advanced to athird position beyond the second distal position, it may release thelock in the obturator housing 980, thereby causing the splines 986 tocollapse and/or the distal portion 982 to retract into the sheath 812.Alternatively, the splines 986 may be collapsed before the clip 805 isejected completely from off of the carrier member 840, or even beforethe pusher member 842 begins to deploy the clip 805. This may avoid anyrisk of contact between the clip 805 and the splines 986.

The relative lengths of the actuator members 876, 878, 880 and thesheath 812 and/or the length of the longitudinal slots 886, 888, 890 maybe set such that the second distal position is at a region proximal tothe wall 898 of the vessel 890. For example, as shown in FIG. 44H, itmay be desirable to deploy the clip 805 within intervening tissuebetween the patient's skin and the wall 898 of the vessel 890.Alternatively, as shown in FIG. 44I, the clip 805 may be deployed suchthat the tines 807 are driven into or through the wall 898 of the vessel890.

Once the clip 805 is successfully delivered, the apparatus 810 may bewithdrawn from the passage 892. If the splines 864 of the locator member814 are not automatically collapsed during advancement of the housing824, the splines 864 may be affirmatively collapsed, e.g., by depressingthe switch 988. The entire apparatus 810 may then be removed in onestep. Alternatively, as in the embodiment of FIGS. 43A and 43B, if theobturator assembly 1118 is separable from the actuator assembly 1116, itmay be withdrawn from the sheath 812 before withdrawing the actuatorassembly 1116 and/or sheath 1112.

Thus, the clip 805 remains in place within the wall 898 of the vessel890 or in the surrounding tissue 896 adjacent the vessel 890 to closeand/or seal the passage 892. The clip 805 may remain substantiallypermanently in the patient's body. Alternatively, the clip 805 may beformed from bioabsorbable material, and may remain until the passage 892is at least partially healed and the clip 805 is absorbed by thesurrounding tissue 896.

VII. Sixth Closure System Embodiment

Turning to FIGS. 45A-46B, another preferred embodiment of an apparatus1210 is shown for sealing a passage through tissue communicating with abody lumen, such as a blood vessel, in accordance with the presentinvention. Generally, the apparatus 1210 includes a plug member 1212, anelongate shaft or handle device 1214, and a locator member 1216.

With particular reference to FIGS. 45A and 45B, the locator member 1216includes a helically wound wire 1244 that includes proximal and distalends 1246, 1248, defining a longitudinal axis 1238 therebetween. Thehelically wound wire 1244 may be formed from flexible material that isbiased to assume an axial configuration, as shown in FIG. 45A, but maybe deflectable, e.g., by buckling, as explained further below. Thehelically wound wire 1244 has a diameter such that the locator member1216 may be advanced through a lumen 1240 of the handle device 1214 (asshown in FIGS. 46A and 46B) and/or directly into a passage throughtissue. Preferably, adjacent turns of the helically wound wire 1244 arein close proximity to or substantially abut one another in a relaxedstate free from external forces, yet may be slidable and/or bendablewith respect to one another to facilitate buckling of the locator member1216. Alternatively, adjacent turns of the helically wound wire 1244 mayhave spaces between them in the relaxed state.

In a further alternative, the helically wound wire 1244 may extend onlypartially from the distal end 1248 towards the proximal end 1246 (notshown). In this alternative, the locator member 1216 may include asubstantially straight wire, tubular body, or other proximal portion(not shown) that may extend from the helically wound wire to theproximal end 1246 of the locator member 1216. The proximal portion maybe relatively more rigid, e.g., resistant to buckling than the helicallywound wire and/or may be supported by the wall of the lumen 1240 of thehandle device 1214.

The locator member 1216 also includes a tether or other control element1250 that is coupled to the helically wound wire 1244. Preferably, thetether 1250 is an elongate wire, ribbon, cable, and the like that has adistal end 1252 that is coupled to the distal end 1248 of the helicallywound wire 1244. The tether 1250 may include a handle 1256 on itsproximal end 1258 for selectively pulling the tether 1250 in a proximaldirection to cause the helically wound wire 1244 wire to buckle, asexplained further below.

The tether 1250 may extend along an outer surface of the helically woundwire 1244 at least partially from the distal end 1248 towards theproximal end 1246, thereby defining a deflectable distal portion 1254.For example, the tether 1250 may extend along the outer surface of thehelically wound wire 1244 along its entire length. Alternatively, thetether 1250 may extend along the outer surface of the distal portion1254, and then may pass between turns of the helically wound wire 1244,and extend within the helically wound wire 1244 to the proximal end 1246of the locator member 1216. In a further alternative, the tether 1250may extend its entire length within the helically wound wire 1244. Forexample, if the helically wound wire 1244 has gaps between adjacentturns, the helically wound wire 1244 may be compressed when the tether1250 is pulled to cause the helically wound wire 1244 to buckle.

An actuator (not shown) may be provided on the proximal end 1246 of thelocator member 1216. The actuator may be coupled to the proximal end1258 of the tether 1250 and to the helically wound wire 1244 forproviding controlled relative movement of the tether 1250 and thehelically wound wire 1244, as will be appreciated by those skilled inthe art.

When the proximal end of the tether 1250 is in its distal-most position,the helically wound wire 1244 may extend generally parallel to thelongitudinal axis 1238, thereby defining an axial or inactivatedconfiguration, such as that shown in FIG. 45A. Even if the distalportion of the helically wound wire 1248 becomes slightly curved, e.g.,when inserted into a body lumen, the distal portion is still considered“generally parallel” to the longitudinal axis 1238. When the tether 1250is directed proximally, e.g., by applying a proximal force on theproximal end 1258 and/or handle 1256, it may pull the distal end 1248 ofthe helically would wire 1244 towards the proximal end 1246, therebycausing the distal portion 1254 of the helically wound wire 1244 tobuckle, thereby assuming a transverse or activated configuration, suchas that shown in FIG. 45B.

Turning to FIGS. 46A and 46B, the plug member 1212 is a body, preferablyhaving a generally cylindrical shape, including a proximal end 1220, adistal end 1222, and an outer surface 1230. The plug member 1212includes a lumen 1224 that extends between a proximal opening 1226 and adistal opening or port 1228. The plug member 1212 may be formed frombiocompatible material, and preferably from bioabsorbable material,and/or may be substantially rigid or partially flexible.

The plug member 1212 generally includes a helical thread pattern 1218,including one or more helical threads, that extends at least partiallybetween its proximal and distal ends 1220, 1222. The helical threadpattern 1218 is preferably substantially rigid and may have asubstantially square cross-section to facilitate sealing of a passageinto which the plug member 1212 is threaded.

A sealing member (not shown) may be provided within the lumen 1224 forsubstantially sealing the lumen 1224 from fluid flow therethrough. Thesealing member is preferably formed from a material that expands whenexposed to fluids, e.g., a gel foam, and may be bioabsorbable, e.g., ifthe plug member 1214 is. Before exposure to fluid, the sealing membermay be substantially recessed from the lumen 1224, thereby accommodatinginserting devices therethrough. Upon exposure to fluid, e.g., blood, thesealing member may expand, e.g., due to hydration and the like, acrossthe lumen 1224 and/or otherwise substantially seal the lumen 1224.

Alternatively, the sealing member may be a valve (not shown) or a coilof material that is biased to substantially seal the lumen 1224 fromfluid flow. For example, the sealing member may be biased tosubstantially seal the lumen 1224, yet may be deflected to accommodateinsertion of one or more devices therethrough. In a further alternative,the lumen 1224 may have a relatively small cross-section, and thesealing member may be omitted.

Additional information regarding plug members appropriate for use withthe present invention may be found in U.S. Pat. No. 5,292,332 to Lee andU.S. Pat. No. 5,290,310 to Makower et al., the disclosures of which areexpressly incorporated herein by reference.

Returning to FIGS. 46A and 46B, the handle device 1214 has a proximalend 1234, a distal end 1236, and a lumen 1240 that extends between theproximal and distal ends 1234, 1236, e.g., for accommodating insertionof the locator member 1216 and/or other devices therethrough. A handle1242 may be provided on the proximal end 1234 of the shaft 1214 forfacilitating manipulation of the apparatus 1210, e.g., to facilitaterotation of the apparatus 1210 into a passage, as described below.Preferably, the handle device 1214 is a substantially rigid tubularmember having a cross-section that is substantially smaller than across-section of the plug member 1212, e.g., to minimize dilation of apassage into which the plug member 1212 is inserted.

The plug member 1212 and the distal end 1236 of the handle device 1214generally include one or more connectors (not shown) for releasablysecuring the plug member 1212 to the handle device 1214, as described inapplication U.S. Pat. No. 6,780,197, which is incorporated herein byreference. Preferably, cooperating connectors (not shown) substantiallycouple the plug member 1212 to the handle device 1214 such that the plugmember 1212 cannot move independently of the handle device 1214, e.g.,such that the plug member 1212 may be rotated only by rotating thehandle device 1214. Preferably, the handle 1242 includes an actuator(not shown) that may be activated to release the connectors securing theplug member 1212 to the handle device 1214.

When the locator member 1216 is fully inserted into the handle device1214, the distal portion 1254 of the locator member 1216, is preferablydisposed beyond the distal end 1236 of the handle device 1214, and, morepreferably, beyond the distal end 1222 of the plug member 1212, as shownin FIG. 46B. The locator member 1216 may be coupled to the handle device1214, e.g., by cooperating detents or other connectors on theirrespective proximal ends 1246, 1234. All of the distal portion 1254 ofthe locator member 1216 may be disposed beyond the distal end 1222 ofthe plug member 1212, or a portion of the distal portion 1254 may extendinto the lumen 1224 of the plug member and/or the lumen 1240 of thehandle device 1214.

Turning to FIGS. 47A-47D, during use, the apparatus 1210 may be used toseal and/or close a passage through tissue 896, such as a puncture 892communicating with a blood vessel 890 or other body lumen. Initially,the plug member 1212 may be connected to or otherwise disposed on thehandle device 1214. The locator device 1216 may be inserted into thehandle device 1214 until the distal portion 1254 extends beyond the plugmember 1212, as shown in FIG. 46B (but with the distal portion 1254 inits axial configuration as shown in FIGS. 47A and 47B).

The puncture 892 may be used to provide percutaneous access to thevessel 890. For example, the puncture 892 may facilitate performing anendovascular procedure within a patient's vasculature, such asangioplasty, stenting, atherectomy, and the like, or may otherwiseprovide access via the vessel 890 to a region within the patient's body.Upon completion of the procedure, any instruments, such as an introducersheath (not shown), may be removed from the vessel 890 and puncture 892.

The apparatus 1210 may then be introduced into the puncture 892, forexample, by initially inserting the distal portion 1254 of the locatormember 1216 into the puncture 892. The distal portion 1254 may have asubstantially atraumatic distal tip, e.g., tapered and/or relativelyflexible, to facilitate advancement of the apparatus 1210 into thepuncture 892. As the distal portion 1254 of the locator member 1216 isadvanced into the puncture 892, the plug member 1212 may be insertedinto the puncture 892, as shown in FIG. 47A.

Because of the thread pattern 1218, the handle device 1214 may berotated in a first direction to thread the plug member 1212 into thepuncture 892. Consequently, the outer surface 1230 and/or the threadpattern 1218 may engage tissue 896 surrounding the puncture 892, therebysubstantially sealing the puncture 892 from fluid flow, such as bloodflow, within the vessel 890. The apparatus 1210 may be rotated in thefirst direction about its longitudinal axis 1238 to thread the plugmember 1212 substantially atraumatically deeper into the puncture 892.

Turning to FIG. 47B, as the plug member 1212 is advanced, the distalportion 1254 of the locator device 1216 eventually passes through thewall 898 of the vessel 890. This advancement may be monitored byproviding one or more radiopaque markers (not shown) and the like on thehandle device 1214, the plug member 1212, and/or the locator member1216, and using fluoroscopy while advancing the apparatus 1210.Alternatively, depth markers (not shown) may be provided on the exteriorof the handle device 1214 for visual monitoring advancement. Tactileindication, e.g., resistance to further advancement, may also identifythat the vessel 890 has been attained.

Once it is confirmed that the distal portion 1254 is located within thelumen 890, the locator member 1216 may be activated, e.g., by pullingthe handle 1256 proximally or activating an actuator (not shown) at theproximal end of the locator member 1216. This causes the distal portion1254 to buckle to its transverse configuration, as shown in FIG. 47C. Inthe transverse configuration, the distal portion 454 has a cross-sectionsuch that the distal portion 454 may not be withdrawn into the plugmember 1212 and/or the puncture 892.

Rotation of the apparatus 1210 may then be reversed, i.e., in a seconddirection opposite the first direction, to withdraw the plug member 1212a predetermined distance relative to the vessel 890. As the plug member1212 is withdrawn, the distal portion 1254 of the locator member 1216may engage a wall 898 of the vessel 890, thereby creating resistance tofurther rotation. This may provide tactile feedback that the plug member1212 is disposed at a desired location, e.g., within the puncture 892 inclose proximity to the vessel 890, but not extended into the vessel 890.

The plug member 1212 may then be released from the handle device 1214.The locator member 1216 may be deactivated, i.e., returned to its axialconfiguration, and then withdrawn from the plug member 1212, eithersimultaneously with withdrawal of the handle device 1214 or beforewithdrawal of the handle device 1214. The sealing member (not shown)preferably substantially seals the lumen 1224 (not shown, see FIGS. 46Aand 46B) within the plug member 1212 to prevent fluid within the vessel890 from passing therethrough to leak from the puncture 892.Alternatively, leakage through the lumen 1224 may be sufficientlyinsignificant, e.g., hemostatis may occur rapidly despite the presenceof the lumen 1224, and the sealing member may be eliminated.

Preferably, as explained above, the sealing member is a material thatexpands when exposed to fluid. For example, as the locator member 1216is withdrawn (either before or along with the handle device 1214),fluid, e.g., blood, may flow proximally through the lumen 1224 in theplug member 1212, e.g., until it encounters the sealing member. Althougha relatively small amount of fluid may pass beyond the sealing member,the sealing member may expand substantially due to the fluid contactuntil it substantially seals the lumen. Alternatively, the sealingmember may be a valve that may open to accommodate the locator member1216, but may automatically close upon withdrawal of the locator member1216.

If the plug member 1212 is bioabsorbable, it may remain within thepuncture 892 as the tissue heals, thereby allowing the wall 898 of thevessel 890 and tissue 896 surrounding the passage 892 to at leastpartially heal before the plug member 1212 is absorbed. Alternatively,the plug member 1212 may be retrieved once the tissue between the plugmember 1212 and the vessel 890 has substantially healed.

In an alternative embodiment, a guidewire (not shown) may be used duringthe procedure. The apparatus 1210 may be provided initially without thelocator member 416, and the guidewire may be backloaded through the plugmember 1212 and handle device 1214. The guidewire may be used to guidethe plug member 1212 as it is threaded through the puncture 892 until itat least partially enters the vessel 890. Once the vessel 890 has beenattained, the guidewire may be withdrawn, and the locator member 1216may be inserted through the handle device 1214 until the distal portion1254 extends beyond the plug member 1212 into the vessel 890. The distalportion 1254 may be activated, and then the procedure may proceedsubstantially as just described to deliver the plug member 1212.

In a further alternative, the locator member 1214 shown in FIGS. 45A and45B may be used to position and/or deliver other closure elements. Forexample, the locator member 1214 may be substituted for the locatormember with expandable positioning elements to deliver a clip within ahousing that is slidable along a sheath (not shown) through which thelocator member 1216 may be inserted. In yet another alternative, thelocator member with expandable positioning elements shown and describedabove in connection with FIGS. 33-35B may be used in place of thelocator member 1216 to position and/or deliver the plug member 1212,using methods similar to those described above.

Turning to FIGS. 49A-49D, an apparatus 1210 may be used in conjunctionwith an introducer sheath 1202 or other tubular member already in placewithin the passage 892. For example, the introducer sheath 1202 may beused to access the vessel 890 to perform a procedure within thepatient's vasculature or elsewhere within the patient's body, asdescribed above. The sheath 1202 may be disposed such that a proximalend 1204 is located outside the passage 892, and a distal end 1206 islocated within the vessel 890.

As shown in FIG. 49A, the locator member 1216 may be inserted throughthe introducer sheath 1202 until the distal portion 1254 extends beyondthe distal end 1206 of the sheath 1202 into the vessel 890. The distalportion 1254 may be buckled from the axial configuration to thetransverse configuration, as described above, and then the locatormember 1216 may be manipulated, e.g., pulled proximally, such that thebuckled distal portion 1254 engages or otherwise contacts a proximalwall 892 of the vessel 890. Thus, the locator member 1216 may be securedfrom proximal movement relative to the vessel 890 and/or may providetactile feedback of the location of the distal portion 1216. The sheath1202 may be removed from the passage 892 either before or after bucklingthe distal portion 1254 of the locator member 1216.

The plug member 1212 may then be advanced over the locator 1216 memberinto the passage 892. For example, the plug member 1212, disposed on thedistal end 1236 of an elongate member 1214, may be threaded through thetissue 896 along the passage 892 such that threads 1218 on the plugmember 1212 substantially engage the surrounding tissue 896. The locatormember 1216 may pass through a passage 1224 in the plug member 1212and/or through the lumen 1240 of the elongate member 1214. Once the plugmember 1212 reaches a desired location within the passage 892, the plugmember 1212 may be released from the distal end 1236 of the elongatemember 1214.

To facilitate positioning of the plug member 1212 relative to the vessel890, the locator member 1216 and/or the elongate member 1214 may includeone or more depth markers. For example, the locator member 1216 mayinclude a marker band 1260 at a predetermined location relative to thedistal portion 1254. The elongate member 1214 may include a window 1262or other opening at a predetermined location on its proximal end 1234.When the marker band 1260 on the locator member 1216 appears in thewindow 1262, it may provide a visual indication that the plug 1212 isdisposed at a predetermined position relative to the wall 898 of thevessel 890. Alternatively, the locator member 1216 and the elongatemember 1214 may include other cooperating elements, e.g., cooperatingtactile elements as described above, for identifying when the plug 1212is disposed at a predetermined location.

After the plug 1212 is released from the elongate member 1214, thedistal portion 1254 of the locator member 1216 may be returned to itsaxial configuration, and the elongate member 1214 and the locator member1216 may be withdrawn from the passage 892, leaving the plug member 1212to substantially seal the passage 892, similar the embodiments describedabove.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description. Allchanges which come within the meaning and range of equivalency of theclaims are to be embraced within their scope.

What is claimed is:
 1. A method of closing an opening in a body tissue,the method comprising: elastically deforming an elastically deformableclosure clip into a first closure clip position; positioning theelastically deformed closure clip adjacent to the opening in the bodytissue such that a plurality of spikes extending from an annular portionof the elastically deformed closure clip are insertable into the tissueat a location outward from a central axis of the opening, the annularportion including a plurality of upper members and a plurality of lowermembers, the plurality of upper members and the plurality of lowermembers being curved and concentric about a longitudinal axis extendingthrough the plurality of upper members and the plurality of lowermembers, each upper member being separated from two adjacentlypositioned lower members by a pair of legs, the plurality of spikesextending from the plurality of lower members and including at least apair of oppositely disposed spikes that are elastically separated fromone another in the first closure clip position; inserting the pluralityof spikes into the tissue at a location outward from the central axiswith the opening; and positioning the elastically deformed closure clip,with the annular portion, in a second closure clip position such thatthe plurality of spikes extending from the annular portion areelastically pulled inward toward the central axis of the opening so asto pull the tissue between the opening and each of the spikes togethercausing the oppositely disposed spikes to cross over one another in thesecond closure clip position and close the opening.
 2. The method as inclaim 1, further comprising releasing the elastically deformed closureclip from a distal end of a closure clip applicator when adjacent to theopening in the tissue.
 3. The method as in claim 2, further comprisingpositioning the closure clip applicator adjacent to the opening in thebody tissue using a sheath.
 4. The method as in claim 3, wherein thesheath guides the positioning of the closure clip applicator so that theplurality of spikes are capable of being inserted into the tissue at thelocation outward from the central axis of the opening.
 5. The method asin claim 4, further comprising positioning the sheath relative to theopening in the tissue using a guide.
 6. The method as in claim 5,wherein the guide has a distal portion that extends through the openingof the body tissue and a proximal portion that is disposed within alumen of the sheath during the positioning of the sheath.
 7. The methodas in claim 6, further comprising centering the sheath at the centralaxis of the opening using the guide.
 8. The method as in claim 7,further comprising centering, with the sheath, the spikes of the closureclip around the opening of the tissue with respect to the central axiswhen the closure clip is in the second position.
 9. A method of closingan opening in a body tissue, the method comprising: radially elasticallyexpanding an elastically deformable closure clip into a radiallyelastically expanded first closure clip delivery position; positioning aclosure clip applicator adjacent to the opening in the body tissue, theclosure clip applicator supporting the radially elastically expandedclosure clip at a distal end of the closure clip applicator, theradially elastically closure clip having an annular portion, the annularportion including a plurality of upper members and a plurality of lowermembers, the plurality of upper members and the plurality of lowermembers being curved and concentric about a longitudinal axis extendingthrough the plurality of upper members and the plurality of lowermembers, each upper member being separated from two adjacentlypositioned lower members by a pair of legs, a plurality of spikesextending from each lower member toward the longitudinal axis;positioning the radially elastically expanded closure clip into theradially elastically expanded first closure clip delivery positionadjacent to the opening in the body tissue such that the plurality ofspikes extending from the annular portion of the elastic closure clipare inserted into the tissue at a location outward from a central axisof the opening, the plurality of spikes, extending from the plurality oflower members, including at least a pair of oppositely disposed spikesthat are separated from one another in the radially elastically expandedfirst closure clip delivery position; and elastically contracting theradially elastically expanded closure clip to a radially elasticallycontracted second closure clip deployed position such that the pluralityof spikes extending from the annular portion are elastically pulledinward toward to central axis of the opening so as to pull the tissuebetween the opening and each of the spikes together causing theoppositely disposed spikes to cross over one another in the radiallyelastically contracted second closure clip deployed position and closethe opening.
 10. The method as in claim 9, further comprising releasingthe closure clip from a distal end of the closure clip applicator whenadjacent to the opening in the tissue, wherein the elastic closure clipis formed of a superelastic material.
 11. The method as in claim 10,further comprising positioning the closure clip applicator adjacent tothe opening in the body tissue using a sheath.
 12. The method as inclaim 11, further comprising positioning the sheath relative to theopening in the tissue using a guide.
 13. The method as in claim 12,wherein the guide has a distal portion that extends through the openingof the body tissue and a proximal portion that is disposed within alumen of the sheath.
 14. The method as in claim 13, further comprisingcentering the sheath at the central axis of the opening by using theguide.
 15. The method as in claim 14, further comprising centering, withthe sheath, the spikes of the closure clip around the opening of thetissue with respect to the central axis when the closure clip is in thesecond position.
 16. A method of closing an opening in a body tissue,the method comprising: inserting a guide through the opening in the bodytissue; using the guide to position a closure clip applicator adjacentto the opening in the body tissue with the guide, the closure clipapplicator having an elastic closure clip in a radially elasticallyexpanded first closure clip delivery position at a distal end of theclosure clip applicator, the elastic closure clip having an annularportion, the annular portion including a plurality of upper members anda plurality of lower members, the plurality of upper members and theplurality of lower members being curved and concentric about alongitudinal axis extending through the plurality of upper members andthe plurality of lower members, each upper member being separated fromtwo adjacently positioned lower members by a pair of legs, a pluralityof spikes extending from each lower member toward the longitudinal axis;positioning the radially elastically expanded closure clip into theradially elastically expanded first closure clip delivery positionadjacent to the opening in the body tissue such that the plurality ofspikes extending from the annular portion of the elastic closure clipare inserted into the tissue at a location outward from a central axisof the guide, the plurality of sharpened, tissue-penetrating spikes,extending from the plurality of lower members, including at least a pairof oppositely disposed spikes that are separated from one another in theradially elastically expanded first closure clip delivery position; andelastically contracting the radially elastically expanded closure clipto a radially elastically contracted second closure clip deployedposition such that the plurality of spikes extending from the annularportion are pulled inward toward to central axis of the guide so as topull the tissue between the opening and each of the spike togethercausing the oppositely disposed spikes to cross over one another in theradially elastically contracted second closure clip deployed positionand close the opening.
 17. The method as in claim 16, further comprisingreleasing the closure clip from a distal end of the closure clipapplicator when adjacent to the opening in the tissue, wherein theelastic closure clip is formed of a superelastic material.
 18. Themethod as in claim 17, further comprising positioning the closure clipapplicator adjacent to the opening in the body tissue using a sheath.19. The method as in claim 18, wherein the guide has a distal portionthat extends through the opening of the body tissue and a proximalportion that is disposed within a lumen of the sheath before the clipcontracts the opening in the body tissue.
 20. The method as in claim 17,further comprising centering, with the sheath, the spikes of the closureclip around the opening of the tissue with respect to the central axiswhen the closure clip is in the second position.
 21. The method as inclaim 1, wherein the annular portion of the elastically deformed closureclip forms a lumen.
 22. The method as in claim 1, wherein the bodilytissue is an outer wall of a blood vessel.
 23. The method as in claim 1,wherein the plurality of spikes comprise four spikes.
 24. The method asin claim 1, wherein the plurality of spikes comprise barbed spikes.